Manufacturer

Alere San Diego, Inc.

49 recalls in our database name Alere San Diego, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 49
Critical: 0
Severe: 1
Most recent: 2024-05-08

Of the 49 recalls from Alere San Diego, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–49 of 49

LowFDA (Devices)·Z-0882-2015·2015-01-14
Alere INRatio 2 Monitors Recalled for Potential Inaccurate INR Results
Alere San Diego, Inc. is recalling INRatio 2 PT/INR monitors because they may provide results significantly lower than reference laboratory methods.
Product
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement M
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1928-2014·2014-07-02
Alere Triage BNP Calibrators Recalled Due to Mislabeling
Alere San Diego is recalling BNP calibrators because a Level 5 bottle contains Level 4 material, causing calibration failures.
Product
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 the In Vitro quantitative measurement of B-type natriureti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1727-2014·2014-06-18
Alere Triage D-Dimer Test Recalled for Incorrect Manufacturing
Alere San Diego, Inc. is recalling 373 kits of the Alere Triage D-Dimer Test (Lot W53884B) because they may generate error codes or incorrect results.
Product
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 products containing D-dimer in EDTA anticoagulated whole
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1546-2014·2014-05-14
Alere INRatio2 Test Strips Recalled for Inaccurate INR Results
Alere San Diego, Inc. is recalling INRatio2 PT/INR Professional Test Strips because they may report inaccurately low INR results, potentially affecting warfarin therapy monitoring.
Product
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 international normalized ratio (INR) in fresh, capillary whol
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1540-2014·2014-05-14
Alere Triage BNP Test Recalled for Potential Out-of-Range Results
Alere San Diego, Inc. is recalling specific lots of the Alere Triage BNP Test because they may not recover within range when tested with certain controls.
Product
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 congestive heart failure (heart failure), as an aid in the a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1214-2014·2014-03-26
Alere Triage TOX Drug Screen Recalled for False Negative PCP Results
Alere San Diego, Inc. is recalling specific lots of the Alere Triage TOX Drug Screen because they produce false negative results for PCP more often than stated in the package insert.
Product
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 fluorescence immunoassay to be used with the Alere Tri
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0653-2014·2014-01-15
Alere Recalls Oral Fluid Drug Screen Devices Due to Choking Risk
Alere is recalling specific lots of Oral Fluid Drug Screen Devices because the sponge may dislodge, creating a choking hazard.
Product
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 Drug Test. Type of Packaging: 25 individually po
Category
Medical Device
Distribution
4 states
LowFDA (Devices)·Z-0379-2014·2013-12-04
Alere Cholestech LDX Lipid Profile-GLU Test Cassettes Recalled for Labeling Error
Alere San Diego, Inc. is recalling 3,621 kits of Cholestech LDX Lipid Profile-GLU test cassettes because an incorrect lot number was printed on the packaging.
Product
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 cassettes. Product packaging: 10 individually pouched
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0053-2014·2013-10-30
Alere Triage TOX Drug Screen Control 1 Recalled Due to Code Chip Failure
Alere San Diego, Inc. is voluntarily recalling Alere Triage TOX Drug Screen Control 1 because a provided code chip causes the control to fail in QC Sample Mode.
Product
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 test materials, or every 30 days, and as otherwise
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1401-2013·2013-06-05
Alere hCG Combo Cassette Kits Recalled for Incorrect Packaging Inserts
Alere San Diego, Inc. is recalling 3,975 hCG Combo Cassette kits because some were packaged with the wrong product insert.
Product
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 or urine, as an aid in the early detection of pregnancy
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1344-2013·2013-05-29
Alere Recalls Cardinal Health hCG Cassette Rapid Test Due to Packaging Error
Alere San Diego is recalling 2,167 Cardinal Health hCG Cassette Rapid Test kits because they were incorrectly packaged in boxes for a different test type.
Product
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) in urine, as an aid in the early detection of pregnancy
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1178-2013·2013-05-01
Alere Cholestech LDX hsCRP Test Cassette Recall for Imprecision
Alere San Diego, Inc. is recalling 2,333 Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassettes due to increased imprecision that may affect quantitative results.
Product
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 sensitivity C-Reactive Protein (hsCRP) is an in vitro di
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1139-2013·2013-04-24
Alere Cholestech LDX ALT AST Test Cassette Recalled for Humidity Impact
Alere San Diego is recalling 38,571 ALT AST test cassettes because humidity changes may impact test results.
Product
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1148-2013·2013-04-24
Alere Recalls Mononucleosis Rapid Test Devices Due to False Negative Risk
Alere San Diego is recalling 78 kits of the Clearview Mononucleosis Cassette because the positive control may produce false negative results.
Product
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 heterophile antibodies in whole blood to aid in the diagnosi
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0747-2013·2013-02-06
Alere Cholestech LDX Calibration Verification Recall for HDL Errors
Alere San Diego, Inc. is recalling 614 kits of Cholestech LDX Calibration Verification due to out-of-range HDL cholesterol results.
Product
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), tr
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0746-2013·2013-02-06
Alere Cholestech LDX Multianalyte Control Recalled for HDL Errors
Alere San Diego, Inc. is recalling Alere Cholestech LDX Multianalyte Control kits because they may produce out-of-range HDL cholesterol results.
Product
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), high density lipoprotein cholesterol (HDL), triglyceri
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0029-2013·2012-10-17
Alere Recalls Triage TOX Drug Screen Kits Due to Mislabeled Boxes
Alere San Diego, Inc. is recalling Triage TOX Drug Screen kits because the boxes containing the test devices were mislabeled.
Product
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 presence of drug and/or the major metabolites above the thre
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2460-2012·2012-10-03
Alere Triage TOX Drug Screen 9 Panel Recalled for Meter Calibration Issues
Alere San Diego is recalling 591 kits of the Alere Triage TOX Drug Screen 9 Panel because code chips may not set threshold ranges correctly in meters.
Product
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 and/or the major metabolites above the threshold concentr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2039-2012·2012-07-25
Alere Triage Tox+MTD Drug Screen Recalled for Decreased Precision and Accuracy
Alere San Diego is recalling 9,997 Triage Tox+MTD Drug Screen kits because they may produce false positive or negative results due to decreased precision and accuracy.
Product
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 and/or the major metabolites above the threshold concentr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1932-2012·2012-07-18
Alere Triage D-dimer Kits Recalled for Decreased Precision
Alere San Diego is recalling 1,972 Triage D-dimer kits because certain lots may have decreased precision, potentially leading to false positive or negative results.
Product
Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1930-2012·2012-07-18
Alere Triage Profiler SOB Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 5,013 kits of the Triage Profiler SOB Panel because certain lots may have decreased precision, potentially leading to false positive or negative results.
Product
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1928-2012·2012-07-18
Alere Triage CardioProfiler Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 16,962 kits of the Alere Triage CardioProfiler Panel due to decreased precision that may cause false positive or negative results.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1929-2012·2012-07-18
Alere Triage Cardiac Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 6,044 kits of the Alere Triage Cardiac Panel due to decreased precision that may cause false positive or negative results.
Product
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1931-2012·2012-07-18
Alere Triage BNP Kits Recalled for Potential Inaccurate Heart Failure Results
Alere San Diego, Inc. is recalling 30,083 Triage BNP kits nationwide due to decreased precision that may cause unpredictable false positive or negative results.
Product
Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
Category
Medical Device
Distribution
Distributed nationwide