Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
FDA Recall Z-1183-2021 · Posted None
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Recalling FirmOraSure Technologies, Inc.
Recall StatusTerminated
Product CodeLAF
Date Initiated2021-02-05
Date Terminated2023-03-30
Product Quantity16 units
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.
Firm 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
Root Cause
Packaging process control
Distribution Pattern
US Nationwide distribution in the states of KS, NJ, OH, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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