BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobi

FDA device recall Z-0232-2023 · posted 2022-11-14 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control (QC) testing of the panel batch passes, delaying treatment of the patient with the most appropriate antibiotic

Action taken

BD initiated the recall on October 13, 2022 via Urgent Medical Device Product Advisory states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above and ensure the contents of this Product Advisory are read and understood. 2. It is recommended to suspend reporting of Minocyline AST results to clinicians for the affected lot. 3. Share and post this Product Advisory letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 4. 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 per FDA requirements. BD Contact US Contact Information Areas of Support North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LON

Quantity affected

13,900 EA

Distribution

US Nationwide distribution.

Date initiated

2022-10-13

Date posted

2022-11-14

Location

Sparks, MD

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