Data / Medical devices / United States / Instrumentation Laboratory Co.
Instrumentation Laboratory Co.: FDA-registered device maker in Bedford, MA, United States, 78 510(k) clearances
Instrumentation Laboratory Co. is registered with the FDA (registration 1217183) in Bedford, MA, United States. It lists 45 device types. The FDA files 78 510(k) clearances under its listings, the newest dated July 24, 2025. 39 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1217183
- Address
- 180 Hartwell Rd., Bedford, MA, United States, 01730
- Owner or operator
- Instrumentation Laboratory Co. (1217183)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- September 20, 2005
- Registered through
- 2026
- Brand names listed
- 4-QCYO - Whole Blood CO-Oximeter Optical QC Filters, 4-TMPB - Whole Blood CO-Oximeter Temperature Probe, 70068 - EQC, 85047 - WQC, 85053 - Aspirin Test, 85053-10 - Aspirin Test, 85062 - Preventative Maintenance Kit, 85063 - Validation Kit 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2025 | K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | KQJ | Substantially Equivalent | Instrumentation Laboratory (IL) Co. | accessdata.fda.gov |
| January 28, 2025 | K243374 | HemosIL CL HIT-IgG(PF4-H) | LCO | Substantially Equivalent | Instrumentation Laboratory (IL) Co. | accessdata.fda.gov |
| August 16, 2024 | K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | GKP | Substantially Equivalent | Instrumentation Laboratory (IL) Co. | accessdata.fda.gov |
| December 29, 2023 | K233790 | ACL TOP 970 CL | JPA | Substantially Equivalent | Instrumentation Laboratory | accessdata.fda.gov |
| December 13, 2023 | K230852 | HemosIL Chromogenic Factor IX | GGP | Substantially Equivalent | Instrumentation Laboratory Company | accessdata.fda.gov |
| September 29, 2023 | K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | JPA | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| August 10, 2023 | K223608 | GEM Premier 7000 with IQM3 | CHL | Substantially Equivalent | Instrumentation Laboratory Company | accessdata.fda.gov |
| June 21, 2023 | K231031 | ACL TOP Family 70 Series | GKP | Substantially Equivalent | Instrumentation Laboratory Company | accessdata.fda.gov |
| March 2, 2023 | K223352 | Tenderfoot | FMK | Substantially Equivalent | Accriva Diagnostics, Inc. | accessdata.fda.gov |
| January 27, 2023 | K223090 | GEM Premier ChemSTAT | CGA | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| July 8, 2022 | K201440 | ROTEM sigma Thromboelastometry System | JPA | Substantially Equivalent | Tem Innovations GmbH | accessdata.fda.gov |
| December 29, 2021 | K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 | JPA | Substantially Equivalent | Accriva Diagnostics, Inc. | accessdata.fda.gov |
| August 20, 2021 | K203790 | GEM Premier 5000 | CHL | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| August 19, 2020 | K200033 | HemosIL von Willebrand Factor Antigen | GGP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| November 22, 2019 | K193041 | Hemochron Signature Elite | JPA | Substantially Equivalent | Accriva Diagnostics, Inc. | accessdata.fda.gov |
| February 16, 2019 | K183555 | GEM Premier ChemSTAT | JFY | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| February 16, 2019 | K183549 | GEM Premier ChemSTAT | JGS | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| February 16, 2019 | K183546 | GEM Premier ChemSTAT | CGA | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| December 29, 2017 | K173403 | GEM Premier 5000 | CHL | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| November 22, 2017 | K172903 | HemosIL D-Dimer HS 500 | DAP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| September 8, 2017 | K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | LCO | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| March 3, 2017 | K170314 | ACL AcuStar | JPA | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| December 14, 2016 | K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) | GKF | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| December 14, 2016 | K160412 | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | CHL | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| December 14, 2016 | K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | CGA | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| October 27, 2016 | K160885 | HemosIL D-Dimer HS | DAP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| September 14, 2016 | K161818 | GEM Premier 3000 | CGA | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| July 8, 2016 | K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | LCO | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| March 3, 2016 | K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) | GKP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| December 21, 2015 | K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls | MSV | Substantially Equivalent | Inova Diagnostics, Inc. | accessdata.fda.gov |
| December 13, 2015 | K150877 | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS | GKP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| July 24, 2015 | K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| August 15, 2014 | K133582 | HEMOSIL D-DIMER HS 500 CONTROL | GGN | Substantially Equivalent | Instrumentation Laboratory | accessdata.fda.gov |
| January 13, 2014 | K133407 | GEM PREMIER 4000 | CHL | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| July 3, 2013 | K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | GGN | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| May 3, 2012 | K112995 | GEM PREMIER 4000 | CEM | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| August 10, 2011 | K101533 | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM | JPA | Substantially Equivalent | Tem Innovations GmbH | accessdata.fda.gov |
| June 18, 2010 | K093623 | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO | CIG | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| May 21, 2010 | K091556 | HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS | MSV | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| March 23, 2010 | K083842 | ROTEM DELTA THROMBOELASTOMETRY SYSTEM | JPA | Substantially Equivalent | Pentapharm GmbH | accessdata.fda.gov |
| March 11, 2010 | K092181 | HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS | MID | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| February 5, 2010 | K090264 | HEMOSIL D-DIMER HS 500, CONTROLS | DAP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| March 13, 2009 | K083518 | ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS | JPA | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| July 31, 2008 | K073042 | HEMOSIL D-DIMER | DAP | Substantially Equivalent | Instrumentation Laboratory | accessdata.fda.gov |
| September 17, 2007 | K070927 | HEMOSIL D-DIMER HS | DAP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| September 22, 2006 | K061598 | HEMOSIL HOMOCYSTEINE AND CONTROLS | LPS | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| February 21, 2006 | K060162 | ACL ELITE; ACL ELITE PRO | JPA | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| October 21, 2005 | K052121 | GEM PREMIER 3000 | CGA | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| August 5, 2005 | K051231 | VERIFYNOW-P2Y12 ASSAY | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| April 26, 2005 | K050544 | HEMOSIL D-DIMER HS | DAP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| February 10, 2005 | K050016 | HEMOCHRON SIGNATURE ELITE | JPA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| October 6, 2004 | K042423 | VERIFYNOW-ASPIRIN ASSAY | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| April 30, 2004 | K040843 | HEMOSIL VON WILLEBRAND ACTIVITY | GGP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| May 16, 2002 | K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| March 28, 2002 | K020798 | HEMOCHRON JR. SIGNATURE + | JPA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| October 16, 2001 | K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| June 6, 2001 | K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | KFF | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| April 13, 2001 | K010379 | IL TEST FREE PROTEIN S | GGP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| December 20, 1999 | K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| November 1, 1999 | K992704 | IL TEST VON WILLEBRAND FACTOR | GGP | Substantially Equivalent | Instrumentation Laboratory CO | accessdata.fda.gov |
| May 3, 1999 | K983475 | HEMOCHRON RESPONSE | KQG | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| April 13, 1999 | K990449 | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE | JPA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| September 30, 1998 | K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT | GJS | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| November 20, 1997 | K972831 | HEMOCHRON CITRATE APTT | GFO | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| August 12, 1996 | K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | JBP | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| November 6, 1995 | K951485 | AVOXIMETER 4000 | JKS | Substantially Equivalent | A-Vox Systems, Inc. | accessdata.fda.gov |
| March 15, 1995 | K944691 | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II | GGN | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| June 30, 1994 | K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | JBP | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| May 18, 1994 | K940432 | MICROCOAGULATION PROTHROMBIN TIME TEST | GJS | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| May 11, 1994 | K940401 | JR. MICROCOAGULATION SYSTEM | JPA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| January 22, 1993 | K923302 | TENDERLETT FINGER | FMK | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| November 4, 1992 | K922075 | AVOXIMETER | DQA | Substantially Equivalent | A-Vox Systems, Inc. | accessdata.fda.gov |
| October 18, 1991 | K913861 | HEMOCHRON(R) KACT | JBP | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| February 26, 1991 | K910105 | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 | GFT | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| November 29, 1990 | K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST | KFF | Substantially Equivalent | Intensive Technology, Inc. | accessdata.fda.gov |
| August 30, 1988 | K882481 | HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II | GGN | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| June 1, 1987 | K870831 | PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA | JPA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| March 1, 1985 | K850542 | SURGICUTT - BLEEDING TIME DEVICE | JCA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 3, 2026 | 99843 | Class I | Ongoing | HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. | accessdata.fda.gov |
| May 21, 2026 | 99128 | Class II | Ongoing | GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health ca | The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae. | accessdata.fda.gov |
| May 8, 2026 | 99115 | Class II | Ongoing | GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 000240 | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. | accessdata.fda.gov |
| January 20, 2026 | 98349 | Class II | Ongoing | GEM Premier 5000 PAK, Part No. 00055360004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program | accessdata.fda.gov |
| December 11, 2025 | 98166 | Class II | Ongoing | The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy. | Potential for microbial contamination. | accessdata.fda.gov |
| November 18, 2025 | 98019 | Class III | Ongoing | HemosIL SynthAFax. Partial Thromboplastin Time Tests. | Recalled lots were manufactured with double the amount of preservative concentration. | accessdata.fda.gov |
| February 3, 2025 | 97093 | Class II | Ongoing | HemosIL LMW Heparin Controls; Part Number: 0020300200 | Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays. | accessdata.fda.gov |
| December 18, 2024 | 96044 | Class II | Ongoing | HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic | Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range. | accessdata.fda.gov |
| September 29, 2023 | 93313 | Class II | Ongoing | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004 | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in f | accessdata.fda.gov |
| July 13, 2023 | 92831 | Class II | Ongoing | ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS | Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result | accessdata.fda.gov |
| February 3, 2023 | 91748 | Class II | Ongoing | ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311 | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments | accessdata.fda.gov |
| April 8, 2022 | 90012 | Class II | Ongoing | HemosIL ReadiPlasTin, Part No. 0020301400 | Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G. | accessdata.fda.gov |
| February 22, 2022 | 89894 | Class II | Ongoing | ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CT | Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single r | accessdata.fda.gov |
| October 13, 2021 | 88930 | Class II | Ongoing | HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent. | The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result. | accessdata.fda.gov |
| August 25, 2021 | 88627 | Class II | Ongoing | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days | accessdata.fda.gov |
| July 23, 2019 | 83523 | Class II | Terminated | ROTEM ex-tem; US Part No: 503-05-US | Prolonged clotting times | accessdata.fda.gov |
| August 1, 2018 | 80932 | Class II | Terminated | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determinat | There is a potential for increased imprecision, out of range quality controls and prolonged sample results. | accessdata.fda.gov |
| August 2, 2017 | 79165 | Class II | Terminated | Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 | Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results. | accessdata.fda.gov |
| December 18, 2015 | 72972 | Class II | Terminated | HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate | This Lot is not meeting labeled on-board instrument stability claims of 5 days. | accessdata.fda.gov |
| November 21, 2014 | 69824 | Class II | Terminated | HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated | Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times. | accessdata.fda.gov |
| June 3, 2014 | 68578 | Class II | Terminated | ACL TOP (Base), automated coagulation laboratory instrument. | Potential for sample misidentification. | accessdata.fda.gov |
| November 15, 2013 | 66894 | Class II | Terminated | HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | accessdata.fda.gov |
| July 19, 2013 | 65893 | Class II | Terminated | ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | accessdata.fda.gov |
| April 9, 2013 | 65399 | Class II | Terminated | HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy. | Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification. | accessdata.fda.gov |
| August 3, 2012 | 62894 | Class II | Terminated | Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulat | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | accessdata.fda.gov |
| April 11, 2012 | 61522 | Not yet classified | Terminated | Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human c | Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay. | accessdata.fda.gov |
| May 31, 2011 | 58996 | Not yet classified | Terminated | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox 75 test iQM Part Number: 00027407508 150 test iQM Part Number: 00027415008 300 test iQM Part Number : 00027430008 450 test iQM Part Number: 00027445008 | K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL | accessdata.fda.gov |
| May 11, 2011 | 58878 | Not yet classified | Terminated | Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at th | Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID. | accessdata.fda.gov |
| February 14, 2011 | 58060 | Not yet classified | Terminated | Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care d | Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results | accessdata.fda.gov |
| November 11, 2010 | 57274 | Not yet classified | Terminated | ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing. | Sporadically lowered APTT results were observed with the PT/APTT Test Groups. | accessdata.fda.gov |
| August 13, 2010 | 56657 | Not yet classified | Terminated | ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the as | Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves | accessdata.fda.gov |
| June 19, 2007 | 38234 | Not yet classified | Terminated | Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000 | ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube. | accessdata.fda.gov |
| March 27, 2007 | 37719 | Not yet classified | Terminated | GEM Premier 4000 Laboratory Analyzer | Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result | accessdata.fda.gov |
| March 7, 2006 | 35632 | Not yet classified | Terminated | HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, | Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection). | accessdata.fda.gov |
| December 16, 2005 | 34249 | Not yet classified | Terminated | GEM PREMIER 3000 | Software error may report higher results for glucose and lactate | accessdata.fda.gov |
| May 19, 2005 | 32155 | Not yet classified | Terminated | ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent | Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy | accessdata.fda.gov |
| March 4, 2004 | 28485 | Not yet classified | Terminated | ACL Futura Instrument Analyzer | Software may cause instrument to omit step causing reagent carrover which may effect patient test result | accessdata.fda.gov |
| August 28, 2003 | 27163 | Not yet classified | Terminated | Lactate Disposable Membrane Caps Product Number: 0018108400 | Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L. | accessdata.fda.gov |
| March 7, 2003 | 25810 | Not yet classified | Terminated | GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use | Incorrect bar code applied to cartridges could result in inaccurate pO2 value | accessdata.fda.gov |
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Updated October 10, 2026. 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.