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MicroScan
Beckman Coulter, Inc. · Model B1017-306 · UDI-DI 15099590657680
10
510(k) clearances
98
Adverse events (2 deaths)
13
Recalls
13
Facilities
Description
Neg Breakpoint Combo Panel Type 30
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-08 | Beckman Coulter, Inc. | Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. |
| 2025-07-24 | Beckman Coulter, Inc. | Due to the likely presence of contamination in well(s). |
| 2025-06-25 | Beckman Coulter, Inc. | Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics |
| 2018-05-04 | Beckman Coulter Inc. | The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported. |
| 2015-12-01 | Beckman Coulter Inc. | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organi |
| 2015-12-01 | Beckman Coulter Inc. | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organi |
| 2015-12-01 | Beckman Coulter Inc. | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organi |
| 2015-12-01 | Beckman Coulter Inc. | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organi |
| 2015-12-01 | Beckman Coulter Inc. | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organi |
| 2015-09-10 | Beckman Coulter Inc. | Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or fal |
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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.