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CELL-DYN
ABBOTT LABORATORIES · Model 09H46-02 · UDI-DI 00380740020132
JCB
Prescription
0
510(k) clearances
31
Adverse events
3
Recalls
44
Facilities
Description
CELL-DYN Emerald CLEANER
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-29 | Microcare Medical | Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic deter |
| 2013-11-08 | Beckman Coulter Inc. | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nuc |
| 2013-11-08 | Beckman Coulter Inc. | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nuc |
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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.