—#155855

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.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K082538
Affected lot / code info: Lot 7031818, Exp. Date 2/28/2018

Why it was recalled

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.

Root cause (FDA determination)

Manufacturing material removal

Action the firm took

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 to: BDRC2@bd.com. For further assistance, please contact BD (Customer/Technical) Support at 1-800-638-8663 in the USA.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: CT, VA, PA, TX, FL, NC, WI, NM

Timeline

Recall initiated: 2017-05-11
Terminated: 2018-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155855. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.