PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported December 26, 2012

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.

Recall #
Z-0570-2013
Affected scope
12,250 tests
Initiated
November 6, 2012
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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….

Moderate
severity level
Class II
classification
December 26, 2012
reported

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.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

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.

Recall Profile

Structured summary of the FDA Devices recall record
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.

  • Check the recall number (Z-0570-2013) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

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.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Becton Dickinson & Co.. Units affected: 12,250 tests.
Why was this product recalled?
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 26, 2012. Severity: Moderate. Recall number: Z-0570-2013.
Where was the recalled product distributed?
Distribution: Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

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This recall: FDA Devices, reported December 26, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026