Becton Dickinson & Co.: Medical Device Recall in 2017 - (Recall #: Z-0171-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 11, 2017

Date Posted: December 6, 2017

Recall Number: Z-0171-2018

Event ID: 77370

Reason for Recall:

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.

Status: Terminated

Product Quantity: US: 7750 units

Code Information:

Lot 7031818, Exp. Date 2/28/2018

Distribution Pattern:

CT, VA, PA, TX, FL, NC, WI, NM

Voluntary or Mandated:

Voluntary: Firm initiated