Manufacturer
49 recalls in our database name Alere San Diego, Inc. as the manufacturing or recalling firm.
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.
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.
Abbott is recalling the Cholestech LDX Battery Kit due to a potential for battery swelling that could cause minor burns, cuts, abrasions, or electrical shock to users.
Alere is updating the package insert for Cholestech LDX cholesterol test cassettes to disclose that samples with elevated bilirubin can produce inaccurate triglyceride and HDL results. Approximately 436,990 units are affected.
Alere San Diego, Inc. is recalling 186 Alere Cholestech LDX Analyzer kits because the power supplies have reversed polarity, rendering the devices inoperable.
Alere San Diego, Inc. is recalling specific lots of the Triage Drugs of Abuse Plus TCA 25 Test Kit because they produced unexpected false positive THC results.
Alere San Diego, Inc. is recalling 513 kits of Alere Triage Total 5 Control Level 1 because the product was encoded with incorrect ranges that do not match the Expected Value Card.
Alere San Diego, Inc. is recalling LDX Optical Check Cassettes because the expiration date on the magnetic strip does not match the labeled date.
Alere San Diego is voluntarily recalling INRatio2 PT/INR Testing Systems because some patients showed significantly higher INR results in central laboratories than on the device.
Alere San Diego is voluntarily recalling INRatio2 PT/INR Monitoring Systems because they may report inaccurate INR results, potentially leading to incorrect anticoagulant dosing.
Alere San Diego is voluntarily recalling INRatio PT Monitoring Systems because they may show lower INR results than central laboratory tests, potentially affecting warfarin therapy.
Alere San Diego is voluntarily recalling INRatio test strips because they may report inaccurate INR results, potentially affecting warfarin therapy.
Alere San Diego is voluntarily recalling INRatio 2 home monitors because they may display inaccurate INR results compared to central laboratory tests.
Alere San Diego is voluntarily recalling INRatio2 PT/INR Home Monitoring Systems because they may display inaccurate INR results compared to central laboratory tests.
Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may report inaccurate INR values, potentially leading to incorrect anticoagulant dosing.
Alere San Diego is voluntarily recalling INRatio PT/INR test strips and meters because they may display therapeutic INR values that are significantly higher in central laboratory testing.
Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may show lower INR values than central laboratory tests, potentially affecting warfarin dosing.
Alere San Diego is recalling the Stanbio Rely Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego is recalling Acceava Mono II Rapid Test Strips because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego is recalling Henry Schein One Step + Mono Rapid Test Devices because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego, Inc. is recalling Proadvantage Mono Rapid Test Cassettes because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego is recalling Clearview MONO tests because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego, Inc. is recalling the Cardinal Health Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego is recalling Signify Mono tests because the product labeling incorrectly identifies the positive control material as human plasma.
Alere San Diego is recalling Cholestech LDX Multianalyte Controls because the assigned control ranges for Total Cholesterol and Triglycerides are incorrect.
Alere San Diego, Inc. is recalling INRatio PT/INR Test Strips because the system may provide INR results significantly lower than reference laboratory methods.
Alere San Diego, Inc. is recalling INRatio PT/INR Monitor systems because they may provide INR results significantly lower than reference laboratory methods.