Data / Medical devices / United States / Alere San Diego, Inc.
Alere San Diego, Inc.: FDA-registered device maker in San Diego, CA, United States, 29 510(k) clearances
Alere San Diego, Inc. is registered with the FDA (registration 2027969) in San Diego, CA, United States. It lists 27 device types. The FDA files 29 510(k) clearances under its listings, the newest dated September 20, 2023. 46 recall events name it as the recalling firm (4 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2027969
- FEI number
- 1000125596
- Address
- 9942 Mesa Rim Road 9942 Mesa Rim Road, San Diego, CA, United States, 92121
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- April 19, 2006
- Registered through
- 2026
- Brand names listed
- 1 Step Detects DTX BUP One Step Buprenorpine Single Drug Test (Urine), 1 Step Detects DTX BZO One Step Benzodiazepimes Single Drug Test (Urine), 1 Step Detects DTX COC One Step Cocaine Single Drug Test (Urine), 1 Step Detects DTX OPI One Step Opiate Single Drug Test (Urine), 1 Step Detects DTX OXY One Step Oxycodone Single Drug Test (Urine), 1 Step Detects DTX One Step Multi-Drug Multi-Line Screen Test Device, 1 Step Detects DTX THC One Step Marijuana Single Drug Test (Urine), 1 Step Detects DTX mAMP One Step Methamphetamine Single Drug Test (Urine) 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 |
|---|---|---|---|---|---|---|
| September 20, 2023 | K223179 | Cholestech LDX System | CGA | Substantially Equivalent | Alere San Diego, Inc. | accessdata.fda.gov |
| December 21, 2010 | K102700 | LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS | JJY | Substantially Equivalent | Alere, San Diego, Dba Biosite INcorporated, Dba IN | accessdata.fda.gov |
| November 13, 2006 | K061718 | INNOVACON SPECTRUM II TEST CARD | DKZ | Substantially Equivalent | Innovacon, Inc. | accessdata.fda.gov |
| October 23, 2006 | K062361 | INNOVACON HCG UKTRA TEST DEVICE | JHI | Substantially Equivalent | Innovacon, Inc. | accessdata.fda.gov |
| April 21, 2006 | K060466 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE | DJG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| June 8, 2005 | K050878 | ON CALL MULTI-DRUG HOME TEST CUP | LDJ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| March 11, 2005 | K050050 | ON CALL MULTI-DRUG HOME TEST | LDJ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| February 25, 2005 | K043507 | ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE | DJG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| September 16, 2004 | K041822 | ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE | DKZ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| August 30, 2004 | K041685 | ACON MULTI-CLIN DRUG SCREEN TEST DEVICE | DKZ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| May 19, 2004 | K040445 | ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE | JXN | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| February 17, 2004 | K032903 | ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE | DIO | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| December 12, 2003 | K033299 | ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE | LAF | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| October 28, 2002 | K022589 | ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE | LAF | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 17, 2002 | K021526 | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE | LFG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| December 18, 2001 | K013380 | ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE | DJG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| November 9, 2001 | K012824 | ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE | DIS | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| October 15, 2001 | K012595 | ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE | DJR | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| September 17, 2001 | K012300 | ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE | JXM | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| August 9, 2001 | K011730 | ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE | LCM | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 31, 2001 | K011673 | ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE | DKZ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 31, 2001 | K011672 | ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE | LAF | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 30, 2001 | K011353 | ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE | DJG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 9, 2001 | K010841 | ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE | DIO | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| May 7, 2001 | K010582 | ACON STREP A RAPID TEST STRIP | GTY | Substantially Equivalent | Acon Laboratories Co. | accessdata.fda.gov |
| March 15, 2001 | K003557 | ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) | LDJ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| December 1, 1999 | K993317 | ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) | JHI | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| December 1, 1999 | K993203 | ACON ONE STEP PREGNANCY TEST STRIP (URINE) | JHI | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| October 8, 1999 | K993065 | ACON COMBO PREGNANCY | JHI | Substantially Equivalent | ACON Laboratories, Inc. | 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 20, 2026 | 99409 | Class II | Ongoing | McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-Vue Serum/UrinehCG-STAT, Model/ Part: FHC-A202/23900531, FHC-A | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. | accessdata.fda.gov |
| March 1, 2024 | 94190 | Class II | Ongoing | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user. | accessdata.fda.gov |
| June 24, 2022 | 90508 | Class II | Ongoing | The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick | Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL). | accessdata.fda.gov |
| February 15, 2019 | 83410 | Class II | Terminated | Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette syste | The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable. | accessdata.fda.gov |
| November 14, 2017 | 78608 | Class II | Completed | Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Tria | The recalled lots have demonstrated unexpected false positive THC results. | accessdata.fda.gov |
| October 12, 2016 | 75443 | Class II | Terminated | Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout | Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card. | accessdata.fda.gov |
| August 2, 2016 | 74940 | Class III | Terminated | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to | Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. | accessdata.fda.gov |
| July 11, 2016 | 74665 | Class I | Terminated | Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio 2 PT/INR Monitoring System (Professional Use): The Alere INRatio 2 PT/INR Monitoring System (Professional Use), consisting of t | Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when perf | accessdata.fda.gov |
| June 22, 2016 | 74505 | Class III | Terminated | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM h | The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. | accessdata.fda.gov |
| August 27, 2015 | 72120 | Class III | Terminated | Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test p | Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect. | accessdata.fda.gov |
| December 5, 2014 | 69964 | Class I | Terminated | Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in indiv | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed. | accessdata.fda.gov |
| May 30, 2014 | 68469 | Class III | Terminated | Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for t | Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator Level 5 actually contains Calibrator Level 4. This results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected Level 5 Calibrator. | accessdata.fda.gov |
| May 2, 2014 | 68230 | Class II | Terminated | Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determination of cross-linked fibrin degradation p | Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result. | accessdata.fda.gov |
| April 16, 2014 | 68038 | Class I | Terminated | Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of i | Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. | accessdata.fda.gov |
| March 20, 2014 | 67910 | Class II | Terminated | Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congesti | These lots may not recover within range when tested using certain commercially available controls. | accessdata.fda.gov |
| February 5, 2014 | 67529 | Class II | Terminated | Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen is a fl | Alere San Diego, Inc. is initiating a recall of the Alere Triage TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously report | accessdata.fda.gov |
| October 23, 2013 | 66663 | Class III | Terminated | Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test | Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot # number printed was 321067. | accessdata.fda.gov |
| September 23, 2013 | 66394 | Class III | Terminated | Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of | Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected. | accessdata.fda.gov |
| June 3, 2013 | 66870 | Class II | Terminated | Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid | Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a chok | accessdata.fda.gov |
| April 16, 2013 | 65048 | Class II | Terminated | Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum o | The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere" hCG Cassette (20 mIU/mL) | accessdata.fda.gov |
| March 6, 2013 | 64701 | Class II | Terminated | The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX high sensiti | The Alere Cholestech LDX hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample. | accessdata.fda.gov |
| March 6, 2013 | 64671 | Class II | Terminated | Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST). | The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System. | accessdata.fda.gov |
| February 26, 2013 | 64790 | Class III | Terminated | IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis hete | Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results. | accessdata.fda.gov |
| January 21, 2013 | 49026 | Class III | Terminated | Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG | Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types. | accessdata.fda.gov |
| October 22, 2012 | 63918 | Class III | Terminated | Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC | Out of range (increased) HDL Cholesterol results. | accessdata.fda.gov |
| July 12, 2012 | 63091 | Class II | Terminated | Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug | Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters. | accessdata.fda.gov |
| May 22, 2012 | 61927 | Class I | Terminated | Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens. | Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. | accessdata.fda.gov |
| May 14, 2012 | 62293 | Class II | Terminated | Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug a | A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen. | accessdata.fda.gov |
| March 5, 2012 | 61516 | Not yet classified | Terminated | Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure, an aid in the | Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP, Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300, Lot W48990. Alere San Diego, Inc. has determined that these lots have an increased frequency of Troponin I results >0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional | accessdata.fda.gov |
| January 4, 2012 | 60980 | Not yet classified | Terminated | Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse Panel Plus TCA (K973784), & Triage Drugs of Abuse Panel Plus PPX (K014247) Model Number: 90008, 92002, & 92000 Type of Packagin | Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA. | accessdata.fda.gov |
| October 11, 2011 | 60370 | Not yet classified | Terminated | PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/INR Testing Kit, S | Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus. | accessdata.fda.gov |
| September 1, 2011 | 60959 | Not yet classified | Terminated | Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Rapid Test Device (IST | Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product that were on the market within the expiry period. | accessdata.fda.gov |
| July 1, 2011 | 60519 | Not yet classified | Terminated | Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in | The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928. | accessdata.fda.gov |
| June 10, 2011 | 59101 | Not yet classified | Terminated | Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine. | Alere is initiating a voluntary recall on the listed lots of MULTI-DRUG 9 PANEL INTEGRATED CUP manufactured by Alere for sole use by Calloway Labs due to a mistake that occurred while processing the order, these products were incorrectly labeled as CLIA Waived, when in fact the devices are classified as Moderately Complex. Therefore these devices are misbran | accessdata.fda.gov |
| February 28, 2011 | 59064 | Not yet classified | Terminated | 0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System; 0100007, Alcoho | The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections. | accessdata.fda.gov |
| February 18, 2011 | 58557 | Not yet classified | Terminated | Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) | The recall was initiated due to an issue related to an error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as >500 mg/dL regardless of the true value of the specimen. | accessdata.fda.gov |
| January 12, 2011 | 57715 | Not yet classified | Terminated | SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimen | The recall was initiated after the Investigation of customer-reported complaints, testing of market retention and returned product, It was determined that this lot of product has demonstrated an elevated Incidence of non-specific binding, potentially causing false positive results. A false positive test result could lead to the administration of antibiotics | accessdata.fda.gov |
| November 16, 2010 | 60391 | Not yet classified | Terminated | Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic. | Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability. | accessdata.fda.gov |
| October 6, 2010 | 56985 | Not yet classified | Terminated | Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712. Assayed quality control material for use with the Cholestech LDX System. | The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product. | accessdata.fda.gov |
| March 12, 2010 | 61637 | Not yet classified | Terminated | Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Met | The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen. | accessdata.fda.gov |
| May 28, 2009 | 63175 | Class II | Terminated | Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presen | Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled. | accessdata.fda.gov |
| April 27, 2009 | 52202 | Not yet classified | Terminated | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG | The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time. | accessdata.fda.gov |
| April 27, 2009 | 51925 | Not yet classified | Terminated | Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box. Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determination of myoglobin, c | The recall was initiated because the use of the affected lot may lead to reporting falsely low values for troponin I and myoglobin, possibly resulting in missed or incorrect diagnosis. | accessdata.fda.gov |
| February 6, 2009 | 54276 | Not yet classified | Terminated | Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C. Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and | Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field. | accessdata.fda.gov |
| November 6, 2008 | 50689 | Not yet classified | Terminated | Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine. | The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for customer complaints in the field. In addition, the firm has been able to reproduce false positive results | accessdata.fda.gov |
| December 4, 2007 | 46307 | Not yet classified | Terminated | Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121 | False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots. | accessdata.fda.gov |
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Updated September 25, 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.