Beckman Coulter recalls Synchron Opiate 2000 ng Reagent (OP2) for potential false positive/negative urine drug tests due to cross-reactivity. Affected units include specific catalog numbers and lot ranges.
Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.
Beckman Coulter is recalling Synchron Systems Opiate 2000 ng Reagent (OP2) because certain compounds in urine may cause false test results. This could lead to incorrect drug test outcomes, which is important for accurate health assessments.
The reagent may cross-react with certain compounds in urine, causing false positive or false negative results. This means the test might incorrectly indicate the presence or absence of drugs when they are not actually present.
People using the Synchron Opiate 2000 ng Reagent (OP2) for urine drug testing with UniCel DxC systems are affected. Those with specific catalog numbers and older lot numbers are most at risk.
Check for catalog number 475006 and lot numbers M904147 and older (including M810039, M901087, M904147). The product is sold with UniCel DxC 600/800 systems and SYNCHRON Drugs of Abuse Testing Urine Calibrators.
Verify the catalog number and lot numbers to confirm if your reagent is affected.
The reagent may cause false positive or false negative results due to cross-reactivity with certain compounds in urine.
Synchron Opiate 2000 ng Reagent (OP2) with catalog number 475006 and lot numbers M904147 and older (including M810039, M901087, M904147).
The recall does not require immediate discontinuation; check product details to confirm if your unit is affected.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1751-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1751-2020 from Beckman Coulter. 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.
