Beckman Coulter recalls Access Unconjugated Estriol systems with REF 33570 due to false elevated uE3 results. Affected units have specific serial numbers. No action needed as the hazard is not dangerous in normal use.
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
Beckman Coulter is recalling Access Unconjugated Estriol systems with serial numbers 921133, 921348, and 921742. The recall is due to a chemical interference that can cause false high results for unconjugated estriol tests. This does not pose a safety risk to users.
The system can produce false high results for unconjugated estriol (uE3) due to alkaline phosphatase interference. This may lead to incorrect pregnancy test interpretations but does not cause physical harm.
Pregnant women and healthcare providers using Beckman Coulter Access Unconjugated Estriol systems with serial numbers 921133, 921348, or 921742 are most at risk of inaccurate test results.
Check the serial numbers on the system: 921133, 921348, or 921742. The product is labeled as 'Beckman Coulter Access Unconjugated Estriol, REF 33570'.
Look for serial numbers 921133, 921348, or 921742 on the system.
No, the hazard is only a false high result for uE3 tests, not a physical risk.
No action is needed as the hazard does not cause injury or require immediate discontinuation.
Check the serial numbers; if they match 921133, 921348, or 921742, contact Beckman Coulter for guidance.
We’ve drafted a message you can send Beckman Coul: 1-2 words max to request your refund or repair — edit it as you like.
Subject: Recall Z-3006-2020 — Beckman Coul: 1-2 words max Beckman Coul: 1-2 words max Hello, I own a Beckman Coul: 1-2 words max that is covered by recall Z-3006-2020 from Beckman Coul: 1-2 words max. 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.
