FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology System. Catalog (Ref) Number: 448607
- Recall number
- Z-0232-2023
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology System. Catalog (Ref) Number: 448607
- Status
- Open, Classified
- Initiated
- 2022-10-13
- Posted
- 2022-11-14
- Terminated
- not on file
- Reason
- 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
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 13,900 EA
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI: (10) 1355046 (17) 230131 (30) 0025 (01) 30382904486076 Lot Number: 1355046 Exp. Date: 31JAN2023
- 510(k) numbers
- ["K070809"]
- PMA numbers
- not on file
- Product code
- LON
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28