Bio-Rad recalls BioPlex 2200 ANA Screen Control Sets (REF: 663-1131) that are incompatible with older ANA reagent packs and calibrators. Affected units may cause inaccurate test results.
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
Bio-Rad is recalling BioPlex 2200 ANA Screen Control Sets that don't work with older reagent packs and calibrators. This could lead to inaccurate test results if used with incompatible products.
The control sets are incompatible with older lot numbers of reagent packs and calibrators. This incompatibility can cause inaccurate test results when used together, but does not pose a physical safety risk.
Lab users who own BioPlex 2200 ANA Screen Control Sets (REF: 663-1131, Lot: 51765 or later) and older ANA reagent packs or calibrators are affected. Those using these products for blood tests may see inaccurate results.
Check for BioPlex 2200 ANA Screen Control Sets with reference number 663-1131, lot number 51765 or later. Also look for older reagent packs (REF: 665-1150) and calibrators (REF: 663-1101) with specific expiration dates listed in the recall.
Verify if your BioPlex 2200 ANA Screen Control Set (REF: 663-1131) is compatible with your reagent packs and calibrators by checking the lot numbers and expiration dates.
The BioPlex 2200 ANA Screen Control Sets (REF: 663-1131) are incompatible with older lot numbers of ANA reagent packs and calibrators, which can cause inaccurate test results.
Check if your control set is lot 51765 or later and if your reagent packs or calibrators are from older lots. If incompatible, contact Bio-Rad for guidance.
No physical safety risks are associated with this incompatibility. The main issue is inaccurate test results, which does not pose a risk of injury.
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-0082-2022 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-0082-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
