Recall Z-1183-2021 ยท LAF Gas Chromatography, Methamphetamine
OraSure Technologies, Inc.
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
| Date | Feb 5, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| Action | 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 |
| Quantity | 16 units |
| Distribution | US Nationwide distribution in the states of KS, NJ, OH, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993208 | STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I OraSure Technologies, Inc., Apr 3, 2000 |