Data / Medical devices / United States / Horiba Instruments Incorporated
Horiba Instruments Incorporated: FDA-registered device maker in Canton, MI, United States, 128 510(k) clearances
Horiba Instruments Incorporated is registered with the FDA (registration 1827821) in Canton, MI, United States. It lists 98 device types. The FDA files 128 510(k) clearances under its listings, the newest dated August 11, 2020. 32 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1827821
- Address
- 5449 Research Dr, Canton, MI, United States, 48188
- Owner or operator
- HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical (10083022)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 19, 2021
- Registered through
- 2026
- Brand names listed
- 60--BA0288 Pointe Barbiturate Calibrator/Control (Secobarbital 300 ng/mL), 60-AC0580 Pointe 6-Acetylmorphine Reagent, 60-AC0584 Pointe 6-Acetylmorphine Calibrator (5 ng/mL) Low, 60-AC0586 Pointe 6-Acetylmorphine Calibrator (10 ng/mL) Cutoff, 60-AC0588 Pointe 6-Acetylmorphine Calibrator (20 ng/mL) Intermediate, 60-AC0590 Pointe 6-Acetylmorphine Calibrator (40 ng/mL) High, 60-AC0594 Pointe 6-Acetylmorphine Control (7.5 ng/mL) Level 1, 60-AC0596 Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 128.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2020 | K191296 | Pointe Scientific Creatinine Kinase (CK) Reagent Set | CGS | Substantially Equivalent | Medtest DX | accessdata.fda.gov |
| May 20, 2020 | K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | DHR | Substantially Equivalent | Kamiya Biomedical Company | accessdata.fda.gov |
| March 12, 2020 | K191638 | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | DIO | Substantially Equivalent | Medtest DX | accessdata.fda.gov |
| December 3, 2018 | K181159 | LZI Fentanyl Enzyme Immunoassay | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| April 20, 2018 | DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | QBK | Unknown | Lin-Zhi International, Inc. | accessdata.fda.gov |
| March 22, 2018 | K180074 | Diazyme Lipoprotein (a) Assay | DFC | Substantially Equivalent | Diazyme Laboratories, Inc. | accessdata.fda.gov |
| February 27, 2018 | K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | JGS | Substantially Equivalent | Awareness Technology, Inc. | accessdata.fda.gov |
| June 9, 2016 | K160370 | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer | JGS | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | accessdata.fda.gov |
| September 2, 2014 | K140690 | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER | CDQ | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | accessdata.fda.gov |
| June 13, 2014 | K141055 | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 8, 2014 | K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | LBS | Substantially Equivalent | Carolina Liquid Chemistries Corp. | accessdata.fda.gov |
| February 21, 2014 | K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | DKB | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 26, 2013 | K131556 | DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET | JIT | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| June 1, 2012 | K120763 | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 24, 2012 | K121232 | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR | DBF | Substantially Equivalent | Kamiya Biomedical Company | accessdata.fda.gov |
| May 8, 2012 | K120761 | LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| January 23, 2012 | K113661 | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS | LAF | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| November 22, 2011 | K113139 | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS | DIO | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 15, 2011 | K110298 | OPIATE ENZYME IMMUNOASSAY | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 23, 2011 | K110239 | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL | LDJ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 28, 2010 | K102210 | LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS | DKZ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 6, 2010 | K101195 | 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 31, 2009 | K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | LPS | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| July 30, 2009 | K090844 | BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| February 1, 2008 | K072018 | BS-200 CHEMISTRY ANALYZER, MODE BS-200 | CFR | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | accessdata.fda.gov |
| December 4, 2007 | K070757 | MICROPROTEIN REAGENT SET | JGP | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| November 6, 2007 | K071388 | GENTIAN CYSTATIN C IMMUNOASSAY | NDY | Substantially Equivalent | Gentian AS | accessdata.fda.gov |
| April 30, 2007 | K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | KHS | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| April 13, 2007 | K070207 | MULTI-ANALYTE CHEMISTRY CALIBRATOR | JIX | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| April 11, 2007 | K070504 | AMMONIA/ALCOHOL CONTROL SET | JJY | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| November 9, 2005 | K052148 | TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET | JIT | Substantially Equivalent | Reference Diagnostics, Inc. | accessdata.fda.gov |
| June 30, 2005 | K050283 | CREATININE LIQUICOLOR | JFY | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| December 9, 2004 | K042318 | AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET | JJY | Substantially Equivalent | Aalto Scientific, Ltd. | accessdata.fda.gov |
| June 2, 2004 | K040391 | TOTAL BILIRUBIN REAGENT SET | CIG | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| December 19, 2003 | K033094 | ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) | DKZ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| November 3, 2003 | K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) | DIS | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| October 10, 2003 | K031797 | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) | DJR | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| October 3, 2003 | K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 | DIC | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| September 5, 2003 | K032365 | BENZODIAZEPINE ENZYME IMMUNOASSAY | JXM | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| August 6, 2003 | K031539 | HEMOGLOBIN A1C REAGENT SET | LCP | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| April 28, 2003 | K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS | DDZ | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| March 31, 2003 | K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | JBF | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| February 4, 2003 | K023828 | K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR | DCK | Substantially Equivalent | Kamiya Biomedical Co. | accessdata.fda.gov |
| January 21, 2003 | K023795 | PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) | JXN | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 23, 2002 | K023396 | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | CIJ | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| December 19, 2002 | K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | DRR | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| December 16, 2002 | K023316 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | DLJ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 12, 2002 | K023317 | METHADONE ENZYME IMMUNOASSAY | DJR | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 4, 2002 | K020395 | AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) | DKZ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 10, 2002 | K020763 | COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) | DIO | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 10, 2002 | K020254 | PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 | LCM | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| April 5, 2002 | K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | CEC | Substantially Equivalent | Monobind | accessdata.fda.gov |
| April 3, 2002 | K020769 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | DLJ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| January 8, 2002 | K013062 | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT | MMI | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| December 21, 2001 | K013698 | AST (SGOT) | CIT | Substantially Equivalent | Jas Diagnostics, Inc. | accessdata.fda.gov |
| September 28, 2001 | K011568 | RANDOX LIPOPROTEIN | JIS | Substantially Equivalent | Randox Laboratories, Ltd. | accessdata.fda.gov |
| September 6, 2001 | K012332 | JAS CARBON DIOXIDE LIQUID REAGENT | KHS | Substantially Equivalent | Jas Diagnostics, Inc. | accessdata.fda.gov |
| July 17, 2001 | K011596 | UREA NITROGEN (BUN) LIQUID REAGENT | CDQ | Substantially Equivalent | Jas Diagnostic, Inc. | accessdata.fda.gov |
| October 13, 2000 | K002651 | C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET | DCK | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| October 2, 2000 | K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 | CDZ | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| May 2, 2000 | K000781 | DIRECT TIBC KIT | JMO | Substantially Equivalent | Reference Diagnostics, Inc. | accessdata.fda.gov |
| December 27, 1999 | K993853 | K-ASSAY MULTI-ANALYTE CALIBRATOR | JIX | Substantially Equivalent | Kamiya Biomedical Co. | accessdata.fda.gov |
| November 30, 1999 | K993537 | K-ASSAY TRANSFERRIN | DDG | Substantially Equivalent | Kamiya Biomedical Co. | accessdata.fda.gov |
| September 24, 1999 | K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | DBF | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| September 21, 1999 | K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | DGC | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| August 5, 1999 | K992002 | AUTOHDL CHOLESTEROL REAGENT SET | LBR | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| July 22, 1999 | K991741 | BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 | JHI | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| June 22, 1999 | K991146 | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 | JLW | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| June 22, 1999 | K990993 | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 | JLW | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| June 2, 1999 | K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | KLI | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| June 2, 1999 | K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | CDP | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| January 13, 1999 | K982485 | SERAQUEST CMV IGM | LFZ | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| October 16, 1998 | K982281 | SERAQUEST RUBELLA IGM | LFX | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| October 16, 1998 | K980907 | AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY | LPS | Substantially Equivalent | Axis Biochemicals, Asa | accessdata.fda.gov |
| September 29, 1998 | K983241 | ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS | JJY | Substantially Equivalent | Kamiya Biomedical Co. | accessdata.fda.gov |
| September 29, 1998 | K983130 | LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS | JJY | Substantially Equivalent | Kamiya Biomedical Co. | accessdata.fda.gov |
| July 22, 1998 | K981978 | AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR | MRR | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| October 22, 1997 | K973588 | LIQUID ALKALINE PHOSHATASE REAGENT SET | CJE | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| October 21, 1997 | K971672 | SERAQUEST TOXOPLASMA IGM | LGD | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| October 10, 1997 | K973157 | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET | JQB | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| October 8, 1997 | K973589 | LIQUID LDH-L REAGENT SET | CFJ | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| September 25, 1997 | K972725 | ALCOHOL REAGENT SET | DIC | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| July 20, 1997 | K972671 | BUN (LIQUID) REAGENT SET | CDQ | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| April 21, 1997 | K970781 | LIQUID GLUCOSE (OXIDASE) REAGENT SET | CGA | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| March 11, 1997 | K970560 | URIC ACID (LIQUID) REAGENT SET | KNK | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| January 22, 1997 | K963282 | SERAQUEST HSV IGG | LGC | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| September 4, 1996 | K961053 | SERAQUEST RUBELLA IGG | LFX | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| June 21, 1996 | K961282 | GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 | CFR | Substantially Equivalent | Diagnostic Chemicals , Ltd. | accessdata.fda.gov |
| June 17, 1996 | K960092 | SERAQUEST TOXOPLASMA IGG | LGD | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| June 3, 1996 | K961431 | LACTATE DEHYDROGENASE REAGENT SET | CFJ | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| February 23, 1996 | K954191 | SERAQUEST CMV IGG | LFZ | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| October 7, 1995 | K954074 | AALTO SCIENTIFIC LIQUID CARDIAC CONTROL | JJY | Substantially Equivalent | Aalto Scientific, Ltd. | accessdata.fda.gov |
| May 15, 1995 | K951749 | BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 | JJY | Substantially Equivalent | Biocell Laboratories, Inc. | accessdata.fda.gov |
| November 21, 1994 | K942958 | CREATINE KINASE MB DETERMINATION (UV) | JHW | Substantially Equivalent | Biochemical Trade, Inc. | accessdata.fda.gov |
| August 1, 1994 | K940735 | LIQUID AMYLASE (CNPG3) REAGENT SET | CIJ | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| May 3, 1994 | K941287 | LIQUID ALT(SGPT) REAGENT SET | CKA | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| May 2, 1994 | K941132 | LIQUID AST (SGOT)REAGENT SET | CIT | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| July 28, 1992 | K920449 | POINTE 750 GLYCOMETER | LCP | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| May 13, 1992 | K921625 | CALCIUM-ARSENAZO III REAGENT SET | CIC | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| March 4, 1991 | K910108 | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED | JIN | Substantially Equivalent | Gds Diagnostics | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 10, 2018 | 81160 | Class III | Terminated | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diag | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. | accessdata.fda.gov |
| May 19, 2015 | 71988 | Class II | Terminated | Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6 | A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. For this reason we suggest discontinuing use of the control set. | accessdata.fda.gov |
| May 15, 2015 | 71993 | Class II | Terminated | MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to re | Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end. | accessdata.fda.gov |
| April 3, 2015 | 74234 | Class II | Terminated | Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been at | accessdata.fda.gov |
| March 13, 2015 | 71953 | Class III | Terminated | Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 | Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance. | accessdata.fda.gov |
| December 12, 2014 | 71974 | Class III | Terminated | Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill. | Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications. | accessdata.fda.gov |
| October 23, 2014 | 77062 | Class III | Terminated | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification. | accessdata.fda.gov |
| May 15, 2014 | 77083 | Class III | Terminated | Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap. | The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range. | accessdata.fda.gov |
| March 13, 2012 | 77003 | Class II | Terminated | Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of tota | Decrease reactivity of R 1 component. | accessdata.fda.gov |
| February 15, 2012 | 76985 | Class III | Terminated | Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotrans | A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert. | accessdata.fda.gov |
| October 19, 2011 | 77445 | Class III | Terminated | Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity | Linear performance information in product insert does not match that listed in the approved premarket notification | accessdata.fda.gov |
| July 8, 2011 | 77048 | Class II | Terminated | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met. | accessdata.fda.gov |
| November 22, 2010 | 77453 | Class III | Terminated | The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit | Incorrect control range in product labeling | accessdata.fda.gov |
| December 1, 2009 | 54112 | Not yet classified | Terminated | Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagno | A process deviation occurred during the production of the R1 component which may affect its performance. | accessdata.fda.gov |
| December 1, 2009 | 54094 | Not yet classified | Terminated | Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, | An additional 10% picric acid was added to the R2 component during production. | accessdata.fda.gov |
| November 16, 2009 | 53872 | Not yet classified | Terminated | Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7504-60, I7504-400, I7504-SAM, 10-I7504-60. Clinical c | Turbidity formation could occur, resulting in invalid test results being reported out. | accessdata.fda.gov |
| November 10, 2009 | 53810 | Not yet classified | Terminated | Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc | The firm initiated the recall due to the presence of visible contamination of the product. | accessdata.fda.gov |
| November 10, 2009 | 53784 | Not yet classified | Terminated | Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for repackaging, Catalog # HC902-SAM-911. The produ | Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated. | accessdata.fda.gov |
| October 19, 2009 | 53583 | Not yet classified | Terminated | Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clini | There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL. | accessdata.fda.gov |
| July 29, 2009 | 52851 | Not yet classified | Terminated | Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250. | R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay. | accessdata.fda.gov |
| July 21, 2009 | 77451 | Class III | Terminated | Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator S | Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L. | accessdata.fda.gov |
| February 2, 2009 | 51042 | Not yet classified | Terminated | Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hit | The product performance fails due to precipitation of the R2 component. | accessdata.fda.gov |
| January 29, 2009 | 51044 | Not yet classified | Terminated | Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545- | The R1 reagent has microbial contamination. | accessdata.fda.gov |
| November 3, 2008 | 50131 | Not yet classified | Terminated | Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set, 2MM Corpora | The product is unable to maintain the specification for linearity through the shelf life of the product. | accessdata.fda.gov |
| September 10, 2008 | 49466 | Not yet classified | Terminated | Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R1. (Clinical chemistry) | The inability of the product to maintain stated performance specifications through the stated shelf life. | accessdata.fda.gov |
| August 25, 2008 | 49131 | Not yet classified | Terminated | Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450). For the quantitative determination of aspartate amoinotransferase in | The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results. | accessdata.fda.gov |
| February 7, 2008 | 46783 | Not yet classified | Terminated | Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450, A7516-625, HA916-302 and HA916-492, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Manufactured by Po | May be contaminated with microorganisms. | accessdata.fda.gov |
| December 14, 2007 | 45909 | Not yet classified | Terminated | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188 | Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | accessdata.fda.gov |
| June 12, 2006 | 35497 | Not yet classified | Terminated | Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | accessdata.fda.gov |
| June 9, 2006 | 35499 | Not yet classified | Terminated | Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL. | Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability. | accessdata.fda.gov |
| June 9, 2006 | 35496 | Not yet classified | Terminated | Liquid Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog nos. A7516-150, A7516-450, A7516-625, HA716-246, HA716-2400, H | The reagent may be contaminated with microorganisms. | accessdata.fda.gov |
| June 7, 2006 | 35498 | Not yet classified | Terminated | Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R1 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog number HG420-R1. | Product does not meet performance specifications through its labeled expiration period. | accessdata.fda.gov |
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Updated August 11, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.