Z-0171-2018Class II

BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD...

Name: Z-0171-2018 BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD...
Creator: Becton Dickinson & Co.
Published: 2017-05-11
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-05-11 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of 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... on 2017-05-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0171-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-11
Posted: 2017-11-25
Terminated: 2018-02-06
Recalling firm: Becton Dickinson & Co
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.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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.
Root cause tag: manufacturing process
FDA 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 to: [email protected]. For further assistance, please contact BD (Customer/Technical) Support at 1-800-638-8663 in the USA.
Quantity in commerce: US: 7750 units
Distribution: CT, VA, PA, TX, FL, NC, WI, NM
Product codes and lots: Lot 7031818, Exp. Date 2/28/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0171-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0171-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-25

Product code LON

K082538Class IIBd Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance TestBecton, Dickinson & CO / cleared 2008-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)