OraSure recalls Methamphetamine Intercept Microplate kits with incorrect reagent lot numbers. This may affect test accuracy but does not cause injury. Consumers should check their kit's lot number and contact OraSure for details.
Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.
OraSure is recalling certain Methamphetamine Intercept Microplate kits due to a possible incorrect reagent lot number. This could affect test accuracy but does not pose a safety risk to users.
The kit may contain a different reagent lot number than listed on the box, which could lead to inaccurate test results. However, this does not cause physical harm or injury to users.
People who own or use the Methamphetamine Intercept Microplate kits with lot number 6681090 (expiring March 2021) are affected. Those testing for methamphetamine in oral fluid may be at risk of inaccurate results.
Check the kit's lot number on the box, which should be 6681090 for this recall. The expiration date is March 2021. The unique device identifier (UDI) is 608337000191.
Look for lot number 6681090 on the kit box. If it matches, the kit is affected.
Reach out to OraSure Technologies for further guidance on the recall.
No, this recall does not pose a safety risk. The issue is with test accuracy, not physical harm.
Check the lot number on the kit box. If it's 6681090, contact OraSure for instructions.
The affected kits have lot number 6681090 and expire in March 2021. The unique device identifier (UDI) is 608337000191.
We’ve drafted a message you can send OraSure to request your refund or repair — edit it as you like.
Subject: Recall Z-1183-2021 — OraSure OraSure Hello, I own a OraSure that is covered by recall Z-1183-2021 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.
