CLASS II Device recall · Reported 26 Dec 2012 · FDA Enforcement Report

BD Phoenix Pmic-108 Panels recalled by Becton Dickinson &

Becton Dickinson & is recalling BD Phoenix Pmic-108 Panels, distributed nationwide in the US. The recall was initiated on 6 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 2053373

Quantity recalled12,250 tests

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0570-2013
FDA event ID: 63737
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2012
FDA classified: 19 Dec 2012
Reported: 26 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Nov 2012	Recall initiated by company
19 Dec 2012	Classified by FDA	+43 days
26 Dec 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.

Product as listed by the FDA

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.

Where it was distributed

Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.

Nationwide Arkansas California Kentucky Oklahoma Rhode Island Wisconsin Wyoming

Questions about this recall

Is BD Phoenix Pmic-108 Panels recalled?

Yes. Becton Dickinson & recalled BD Phoenix Pmic-108 Panels on 6 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-0570-2013.

Why was it recalled?

An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.

Which lots are affected?

Lot number 2053373

Where was it sold?

Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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