Bio-Rad recalls BioPlex 2200 APLS IgM reagent kits with incorrect conjugate that may cause false positive or negative test results. Affected kits have specific lot codes and UDI-DI numbers.
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Bio-Rad is recalling APLS IgM reagent packs that were packaged with the wrong chemical, which could cause lab tests to show false positive or false negative results. This means test results might be inaccurate, potentially leading to incorrect health decisions.
The reagent kits contain the incorrect chemical conjugate, which can cause lab tests to give false positive or false negative results. This means test results might not match the actual condition being checked, leading to potential misdiagnosis.
Lab technicians and healthcare providers who use these reagent kits for blood tests. Those who rely on accurate test results for diagnosis are most at risk.
Check for lot code 301538 or UDI-DI number (00)847865000666 on the BioPlex 2200 APLS IgM reagent packs. These kits were sold by Bio-Rad Laboratories, Inc.
Look for lot code 301538 or UDI-DI number (00)847865000666 on the BioPlex 2200 APLS IgM reagent packs.
The reagent kits were packaged with the incorrect conjugate, which could lead to false positive or false negative test results.
Check for lot code 301538 or UDI-DI number (00)847865000666 on the BioPlex 2200 APLS IgM reagent packs.
The recall does not specify a remedy, so contact Bio-Rad Laboratories, Inc. for guidance.
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-1572-2023 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-1572-2023 from Bio-Rad. 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.
