Clark Laboratories recalls Bartels Legionella Urinary Antigen test kits due to potential pipetting issues causing invalid results. Affected units include specific product codes and lots.
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Clark Laboratories is recalling Bartels Legionella Urinary Antigen test kits because contamination during use might cause invalid test results. This could lead to incorrect diagnosis of Legionnaire's disease.
Contamination of the test's conjugate during pipetting can cause the test to produce invalid results. This may lead to incorrect diagnosis of Legionnaire's disease, which requires accurate testing for proper treatment.
Healthcare professionals using the test kits for Legionnaire's disease diagnosis are most at risk. The recall affects specific product codes and lots sold by Clark Laboratories.
Check for product code B1029-440 and lot number 056. The expiration date is November 28, 2022, and the unique device identifier is 05391516744065.
Verify the product code (B1029-440), lot number (056), and expiration date (November 28, 2022).
The recall is due to contamination of the conjugate that may cause pipetting issues, leading to invalid test results.
The recall record does not specify a remedy, so check product details to confirm if it is affected.
The recall indicates a risk of invalid test results, not physical injury or harm.
We’ve drafted a message you can send Clark Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-0382-2022 — Clark Laboratories Clark Laboratories Hello, I own a Clark Laboratories that is covered by recall Z-0382-2022 from Clark Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
