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Alere San Diego, Inc. · Model DMA-102 · UDI-DI 10815845020451
LAF
Prescription
10
510(k) clearances
0
Adverse events
1
Recalls
64
Facilities
Description
mAMP One Step Methamphetamine Test Device
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-05 | OraSure Technologies, Inc. | 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 |
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