Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
This recall has been terminated (originally issued February 5, 2021).
- Company
- Orasure Technologies, Inc.
- Recall Initiated
- February 5, 2021
- Terminated
- March 30, 2023
- Recall Number
- Z-1183-2021
- Quantity
- 16 units
- Firm Location
- Bethlehem, PA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of KS, NJ, OH, VA.
Lot / Code Info
Lot 6681090, Exp date 2021-03. UDI: 608337000191
Root 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