Home › PRO-LAB, INCORPORATED › Microbank (with 2D Barcodes)-Green (80 vials)
Microbank (with 2D Barcodes)-Green (80 vials)
PRO-LAB, INCORPORATED · Model PL.170C/G · UDI-DI 10628429002145
10
510(k) clearances
78
Adverse events
5
Recalls
15
Facilities
Description
Advanced presentation of 80 vials with green caps and beads supplied in a plastic freezer box manufactured from durable plastic with “see through” lids, number locator printed screens, and tube collection device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-30 | bioMerieux, Inc. | There is potential to provide an incorrect organism identification. |
| 2015-11-18 | Hardy Diagnostics | The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination. |
| 2012-12-10 | Becton Dickinson & Co. | Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species. |
| 2012-02-20 | Becton Dickinson & Co. | In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended. |
| 2009-12-21 | Remel, Inc | Product failure - Failure to grow quality control strains of Streptococcus pneumoniae. |
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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.