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Human Apolipoprotein A-1 (Apo A-1) kit for use on SPAPLUS
THE BINDING SITE GROUP LIMITED · Model NK085.S · UDI-DI 05051700016872
JHN
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
9
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-23 | Beckman Coulter Ireland, Inc. | The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B pat |
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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.