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Human C1 Inactivator Kit for use on SPAPLUS
THE BINDING SITE GROUP LIMITED · Model NK019.S.A · UDI-DI 05051700016674
DBA
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
5
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-01 | Quidel Corporation | Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert. |
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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.