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CARDINAL HEALTH
Cardinal Health 200, LLC · Model ORO8108615 · UDI-DI 10195594702809
MLA
Prescription
2
510(k) clearances
190
Adverse events
2
Recalls
4
Facilities
Description
KIT,OB DLVRY, BERGAN MERCY,6 C
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-08-27 | Becton Dickinson & Co. | BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown belo |
| 2013-06-13 | Becton Dickinson & Co. | In vitro diagnostic test kit may exhibit invalid internal negative control 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.