Beckman Coulter recalls Access PCT Reagent Pack (Catalog C53987) for calibration failures on Access 2 and UniCel Dxl systems, potentially delaying lab results. Affected lots 339062 and 439811.
Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
Beckman Coulter is recalling Access PCT Reagent Packs with catalog number C53987 that cause calibration failures on Access 2 and UniCel Dxl systems. This can delay lab results due to repeated calibration attempts.
The reagent lots experience frequent calibration failures with error code "Max Iterate" on specific lab systems. This requires repeated calibration attempts, which delays lab result reporting.
Lab users with Access 2 or UniCel Dxl systems who purchased the Access PCT Reagent Pack (Catalog C53987) from 2023. Most at risk are lab technicians handling these reagents.
Check the catalog number C53987 on the reagent pack. Affected lots are 339062 and 439811. The product was sold with Access 2 and UniCel Dxl systems.
Look for lot numbers 339062 or 439811 on the Access PCT Reagent Pack (Catalog C53987).
The reagent lots experience high rates of calibration failures with error code "Max Iterate" on Access 2 and UniCel Dxl systems, causing delayed lab results.
No action is required as the remedy is not stated in the recall notice.
Check the catalog number C53987 and lot numbers 339062 or 439811 on the reagent pack.
We’ve drafted a message you can send Beckman Coul: A short, human brand name for headings (e.g. to request your refund or repair — edit it as you like.
Subject: Recall Z-1112-2025 — Beckman Coul: A short, human brand name for headings (e.g. Beckman Coul: A short, human brand name Hello, I own a Beckman Coul: A short, human brand name for headings (e.g. that is covered by recall Z-1112-2025 from Beckman Coul: A short, human brand name for headings (e.g.. 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.
