OraSure Technologies, Inc. Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Brand
OraSure Technologies, Inc.
Lot Codes / Batch Numbers
Lot 6681090, Exp date 2021-03. UDI: 608337000191
Products Sold
Lot 6681090, Exp date 2021-03. UDI: 608337000191
OraSure Technologies, Inc. is recalling Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in o due to Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Re. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026