Clark Laboratories Bartels Legionella Urinary Antigen- an adjunct to culture for the recall — FDA Z-0382-2022
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Overview of recall records associated with Clark Laboratories, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 2.
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
This page summarizes recall records in which the official source identifies Clark Laboratories, 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.