OraSure Methamphetamine Test Kit Recalled for Incorrect Reagent Lot Labeling
OraSure Technologies is recalling 16 units of Methamphetamine Intercept Microplate kits due to a labeling error where the wrong lot number was printed on the box.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the source text explicitly states the error should not affect performance, fitting the criteria for cosmetic or documentation issues.
Plain-English summary
OraSure Technologies, Inc. is recalling 16 units of the Methamphetamine Intercept Microplate kit EIA (PN 11041C). The recall is due to a labeling discrepancy where the kit box and specification sheet listed Substrate Reagent (TMB) lot 6676239, but the kits actually contained Substrate Reagent (TMB) lot 6679623.
The affected products are Lot 6681090 with an expiration date of 2021-03. These kits were distributed nationwide in the states of Kansas, New Jersey, Ohio, and Virginia. The source text notes that the incorrect lot inclusion should not affect performance.
Consumers and healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement. This recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
- Manufacturer
- OraSure Technologies, Inc.
- Hazard
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 6681090
- Exp date 2021-03. UDI: 608337000191
Distribution
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