Beckman Coulter recalls SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250) due to potential false positive or negative urine test results from cross-reactivity in certain compounds. Affected units include specific catalog numbers and lot numbers.
The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results.
Beckman Coulter is recalling SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250) because it may give false positive or negative results in urine drug tests. This could lead to incorrect conclusions about barbiturate use, especially if certain compounds in urine interfere with the test.
The reagent may cross-react with certain compounds in urine, causing false positive or negative results. This means the test might incorrectly indicate the presence or absence of barbiturates, potentially leading to wrong conclusions about drug use.
People using the SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250) for urine drug testing are affected. Those who rely on this reagent for barbiturate screening may be at risk of inaccurate test results.
Check for the product name 'SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250)' with catalog number 475012. Affected units include lot numbers M903174, M902167, M801045, M811093, M809230, M807116, M806172, M805116, M804028, M803040, M802093 and older units.
Verify the catalog number (475012) and lot numbers listed in the recall notice to confirm if your reagent is affected.
The reagent may cause false positive or negative results in urine drug tests due to cross-reactivity with certain compounds in urine.
The recall notice does not specify a remedy, so check the product details to see if it is affected and contact Beckman Coulter for further guidance.
Affected lot numbers include M903174, M902167, M801045, M811093, M809230, M807116, M806172, M805116, M804028, M803040, M802093 and older units.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1799-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1799-2020 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.
