# FDA recall Z-1183-2021

> **OraSure Technologies, Inc.** · Class III · device recall initiated 2021-02-05.

## Product

Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

## 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.

## Key facts

- **Recall number:** Z-1183-2021
- **Recalling firm:** OraSure Technologies, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-05
- **Report date:** 2021-03-17
- **Termination date:** 2023-03-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bethlehem, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1183-2021

## Citation

> AI Analytics. FDA recall Z-1183-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1183-2021. Source: US FDA. Licensed CC0.

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