Severity
Moderate
FDA Devices recall · Reported December 26, 2012
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Becton Dickinson & Co. recalled BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson a… - a moderate-severity action.
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson a… was recalled by Becton Dickinson & Co. in December 26, 2012. Reason: An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinical…. Check the official notice for the remedy. Verify recall #Z-0570-2013 with the FDA Devices before acting.
The recall
Becton Dickinson & Co. issued this moderate-severity FDA Devices recall-An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinical….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0570-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0570-2013) was formally reported on December 26, 2012, with the manufacturer initiating the action on November 6, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Becton Dickinson & Co. is listed as the recalling firm, operating out of Sparks, MD. Federal records list the affected scope as 12,250 tests.
The documented reason for this recall is: An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria. Distribution data in the federal record shows the product reached: Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
12,250 tests
Related Recalls
6
3 from same agency
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.
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0570-2013 |
| Date reported | December 26, 2012 |
| Date initiated | November 6, 2012 |
| Recalling firm | Becton Dickinson & Co. |
| Firm location | Sparks, MD |
| Affected scope | 12,250 tests |
| Distribution | Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 26, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.