Methamphetamine Intercept Microplate kit EIA - IVD… recallZ-1183-2021 · OraSure Technologies, Inc. · initiated Feb 5, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OraSure Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Packaging process control
What the company is doing
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
Recall details
- Recall number
- Z-1183-2021
- Status
- Terminated
- Initiated by the company
- Feb 5, 2021
- Recalling firm
- OraSure Technologies, Inc.
- Quantity
- 16 units
- Product code
- LAF
- FDA submissions
- K993208
- Distribution
- US Nationwide distribution in the states of KS, NJ, OH, VA.
Product description
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Code information (models, lots, serial numbers)
Lot 6681090, Exp date 2021-03. UDI: 608337000191
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Methamphetamine Intercept 100 Plate Kit 1104ICOrasure Technologies, Inc. · Gas Chromatography, Methamphetamine1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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