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RDS
AMERICAN BIO MEDICA CORPORATION · Model 10-RSV-065 · UDI-DI 10694644700029
GQG
Prescription
1
510(k) clearances
28
Adverse events
3
Recalls
35
Facilities
Description
RSV Test Kit European 135065
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-03-28 | Binax, Inc. dba IMPD | Tip of the foam swab could detach from the shaft causing injury to the patient. |
| 2004-02-18 | Binax, Inc. | Pouch integrity compromised |
| 2003-12-15 | Becton Dickinson & Co. | Diagnostic test kit may exhibit false positive results. |
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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.