OraSure Technologies recalls cocaine metabolite test kits that may cause false positive results with negative controls. Affected units include specific catalog numbers and expiration dates.
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
OraSure's Cocaine Metabolite MICRO-PLATE EIA test kits may give false positive results due to issues with controls and calibrators. This could lead to incorrect drug test outcomes, especially if used for workplace or legal testing.
The test kit's controls and calibrators can produce false positive results when used with the negative control. This means the test might incorrectly indicate cocaine presence when it's not actually there, potentially causing unnecessary concern or actions.
Users of the Cocaine Metabolite MICRO-PLATE EIA test kits with the specified catalog number and expiration date are affected. People relying on these kits for drug testing may face inaccurate results.
Check for the catalog number 1122SC and expiration date 02/28/2018 on the test kit. The unique device identifier (UDI) is (0100608337000429(17)180228(10)000).
Verify the catalog number 1122SC and expiration date 02/28/2018 on the test kit.
The controls and calibrators in the test kit may cause false positive results with the negative control.
The recall record does not specify a remedy, so check the kit details to confirm if it's affected.
The recall does not mention any physical injury risk, only potential false positive results.
We’ve drafted a message you can send OraSure to request your refund or repair — edit it as you like.
Subject: Recall Z-1419-2018 — OraSure OraSure Hello, I own a OraSure that is covered by recall Z-1419-2018 from OraSure. 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.
