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BinaxNOW® G6PD
Alere Scarborough, Inc. · Model 780-000 · UDI-DI 10811877010705
5
510(k) clearances
7
Adverse events
1
Recalls
6
Facilities
Description
For the qualitative detection of G6PD enzyme activity in blood.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-05-19 | Pointe Scientific, Inc. | A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specif |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.