FDA Device recall Z-1183-2021
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C
- FDA Device
- Class III
- terminated
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class III recall of Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C by Orasure Technologies, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1183-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-02-05 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Orasure Technologies |
| Distribution | US |
Product
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
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.
Identifiers
| code_info | Lot 6681090, Exp date 2021-03. UDI: 608337000191 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1183-2021%22
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