Device product
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 packaged 25 panels to 1 box.
Z-0171-2018
Product summary
- Event
- Event 77370
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 7750 units
- Official record key
device-enforcement:Z-0171-2018
Official wording
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 Staphylococcus infection with clindamycin based on the iMLSb test result. This issue can be detected 100% of the time when used per package insert instructions with iMLSb positive strain S. aureus BAA-977.
Code information: Lot 7031818, Exp. Date 2/28/2018
Distribution pattern: CT, VA, PA, TX, FL, NC, WI, NM
Derived failure modes
-
Unknown
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 Staphylococcus infection with clindamycin based on the iMLSb test result. This issue can be detected 100% of the time when used per package insert instructions with iMLSb positive strain S. aureus BAA-977.