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MicroScan PROMPT
Beckman Coulter, Inc. · Model B1026-10D · UDI-DI 15099590659561
LIE
Prescription
7
510(k) clearances
1
Adverse events
2
Recalls
5
Facilities
Description
Inoculation System-D
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-12-13 | Beckman Coulter Inc. | Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible resul |
| 2006-09-27 | Dade Behring, Inc. | Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing. |
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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.