Recall Z-1183-2021
OraSure Technologies, Inc. · initiated February 5, 2021
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Codes / lots: Lot 6681090, Exp date 2021-03. UDI: 608337000191
Reason for recall
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.
FDA-determined cause: Packaging process control
Action taken
Orasure issued Advisory Letters issued on 2/05/21 via Certified Mail receipt. Letter states reason for recall, health risk and action to take: OraSure Technologies, Inc. has generated a new Specification Sheet for the Methamphetamine Kit with the alternate Substrate Reagent Lot 6679623 included with this advisory letter. Retain testing done using the alternate Substrate Reagent revealed no impact to the kit's performance. If you have any questions regarding this issue please contact out Technical Services Department at technicalserviceQcorasure.coin and they can assist you
Details
- Recall number
- Z-1183-2021
- Initiated
- February 5, 2021
- Terminated
- March 30, 2023
- Product code
- LAF – Gas Chromatography, Methamphetamine
- Quantity
- 16 units
- Distribution
- US Nationwide distribution in the states of KS, NJ, OH, VA.
- Recalling firm
- OraSure Technologies, Inc., Bethlehem, PA