Bio-Rad recalls BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack due to inconsistent CMV IgM analyte results from variable background levels.
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Bio-Rad is recalling a specific reagent pack for CMV IgM testing because results can vary due to background levels in the reagent. This affects lab users who rely on this test for accurate diagnosis.
The CMV IgM analyte in this reagent pack shows variable background levels when handled, leading to inconsistent test results. This can cause false positives or negatives in CMV IgM testing, potentially affecting diagnostic accuracy.
Lab users who purchased the BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack (lot 301388) for CMV IgM testing. Those using the reagent for diagnostic purposes are most at risk of inaccurate results.
Check for the model number 12000670 on the reagent pack. The lot number 301388 is associated with this recall. The reagent is used for CMV IgM testing in laboratory settings.
Verify the model number 12000670 and lot number 301388 on the reagent pack.
The recall is for potential inconsistent results, not safety hazards. The reagent pack can still be used but may produce inaccurate results.
The official recall does not specify a remedy, so no action is required beyond checking the model and lot numbers.
Results may vary due to background levels, potentially causing false positives or negatives in CMV IgM testing.
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-1096-2022 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-1096-2022 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.
