Alere San Diego Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529 recall — FDA Z-3272-2026
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Overview of recall records associated with Alere San Diego, Inc., including dates, categories and classifications where available.
Classification mix: Class III: 9, Class I: 9, Class II: 8.
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
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,…
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…
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…
The recalled lots have demonstrated unexpected false positive THC results.
Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.
Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients…
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients…
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients…
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Test Strips. This action is being initiated as a result of patients who had a therapeutic or…
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients…
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients…
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients…
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients…
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients…
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
This page summarizes recall records in which the official source identifies Alere San Diego, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.