Methamphetamine Intercept Microplate kit EIA - IVD recall: Labeling Error
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Why was Methamphetamine Intercept Microplate kit EIA - IVD recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 6681090, Exp date 2021-03. UDI: 608337000191
- Product
- Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
- Recalling firm
- OraSure Technologies, Inc.
- Quantity
- 16 units
- Distribution
- US Nationwide distribution in the states of KS, NJ, OH, VA.
- Recall date
- March 17, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)