Bio-Rad recalls CMV IgM EIA diagnostic tests due to unusual increases in positivity rates with human IgM antibodies to cytomegalovirus. Affected lots may lead to inaccurate test results.
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Bio-Rad is recalling CMV IgM EIA diagnostic tests because they show unusually high positivity rates with human IgM antibodies to cytome: 1. The recall affects specific lots (B02022, E10022, G05022) of the CMV IgM EIA test. 2. This could lead to inaccurate test results, potentially causing incorrect health assessments.
The test shows higher than expected positivity rates with human IgM antibodies to cytomegalovirus. This could lead to false positive results, potentially causing unnecessary concern or incorrect health decisions.
Healthcare providers and labs using the recalled CMV IgM EIA tests may be affected. Individuals relying on these tests for cytomegalovirus detection could face inaccurate results.
Check the lot numbers on the test: B02022, E10022, or G05022. The product is a CMV IgM EIA in vitro diagnostic test from Bio-Rad Laboratories.
Verify the lot number on the test to see if it matches B02022, E10022, or G05022.
The recall is due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus, which could lead to inaccurate test results.
Check the lot number on the test. If it matches B02022, E10022, or G05022, contact Bio-Rad for guidance.
No, the hazard is limited to potential inaccurate test results, not physical harm.
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-0342-2023 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-0342-2023 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.
