Recall Z-0171-2018 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. --- Product is pac
| Date | May 11, 2017 |
| Status | Terminated |
| Reason | BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test contained on lot 7031818 of Phoenix panels. The iMLSb resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. As the product should not be used when quality control (QC) fails, it is unlikely that there would be any impact on patient results, however, if a customer does not perform QC testing and uses the panel, there is a potential to incorrectly treat a Staphylococ |
| Root cause | Manufacturing material removal |
| Action | URGENT PRODUCT RECALL LETTER (dated May 2017) were sent to customers via a UPS mailing on May 11, 2017. Customers were instructed to discontinue use of the affected lot and discard any remaining product. BD will replace the discarded inventory. Please complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. Please complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or e-mail t |
| Quantity | US: 7750 units |
| Distribution | CT, VA, PA, TX, FL, NC, WI, NM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082538 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST Becton, Dickinson & CO, Nov 20, 2008 |