BD Phoenix PMIC-107 — Class II medical device recall Z-0171-2018
Terminated recall by Becton Dickinson & Co., reported 2017-12-06, distributed in CT, FL, NC, NM, PA, TX, VA, WI. BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrol
| Recall number | Z-0171-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2017-05-11 |
| Classified | 2017-11-25 |
| Reported by FDA | 2017-12-06 |
| Terminated | 2018-02-06 |
| Distributed | CT, FL, NC, NM, PA, TX, VA, WI |
| Quantity | 7,750 units |
| Pathogens | staphylococcus |
| UPC / GTIN / UDI-DI | 30382904484171 |
| Lot numbers | 7031818 |
| Model numbers | 448417 |
| Expiration dates | 2018-02-28 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0171-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.