Z-0570-2013 Class II Terminated
FDA device recall Z-0570-2013 was initiated by Becton Dickinson & Co. on Nov 6, 2012 and is designated Class II. Reason for recall: An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria. The recall status is terminated (terminated Jan 9, 2013). Affected quantity: 12,250 tests.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2012
- Initiation Date
- Nov 6, 2012
- Termination Date
- Jan 9, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,250 tests
Product Description
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
Reason for Recall
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Distribution Pattern
Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
Code Information
Lot number 2053373
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0570-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026