Beckman Coulter recalls Opiate 300 Ng Reagent (OP 1 X 250) for false positive/negative urine drug tests due to cross-reactivity. Affected units include specific lot numbers and catalog numbers.
Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)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 Opiate 300 Ng Reagent (OP 1 X 250) because certain compounds in urine may cause false positive or false negative test results. This could lead to incorrect drug test outcomes for patients using the reagent with specific urine testing systems.
The reagent may cross-react with certain compounds in urine, leading to false positive or false negative results. This means test results could incorrectly indicate the presence or absence of drugs in urine, potentially causing misdiagnosis or unnecessary concern.
Users of the Opiate 300 Ng Reagent (OP 1 X 250) with UniCel DxC 600/800 or SYNCHRON Systems OP 300 urine calibrators. Those who rely on accurate urine drug testing results are most at risk.
Check for Catalog Number 475024 and Lot Numbers M904130 and older including specific listed numbers (M802097, M803045, etc.). The reagent is used with UniCel DxC 600/800 or SYNCHRON Systems OP 300 urine calibrators.
Look for the lot number on the reagent packaging, which should be M904130 or older including specific listed numbers.
The reagent may cause false positive or false negative urine drug test results due to cross-reactivity with certain compounds in urine.
This reagent is used with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 urine calibrators.
Check for Catalog Number 475024 and Lot Numbers M904130 and older including specific listed numbers (M802097, M803045, etc.).
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1752-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1752-2020 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.
