CLASS II Device recall · Reported 19 Dec 2012 · FDA Enforcement Report

BD BBL Taxo XV Factor Strips recalled by Becton Dickinson &

Becton Dickinson & is recalling BD BBL Taxo XV Factor Strips, distributed nationwide in the US. The recall was initiated on 22 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 2089253

Quantity recalled650 vials

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-0523-2013
FDA event ID: 63723
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 22 Oct 2012
FDA classified: 13 Dec 2012
Reported: 19 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Oct 2012	Recall initiated by company
13 Dec 2012	Classified by FDA	+52 days
19 Dec 2012	Published in enforcement report	+6 days

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

Reason for recall

In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.

Product as listed by the FDA

BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***

Where it was distributed

Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico

Nationwide

Questions about this recall

Is BD BBL Taxo XV Factor Strips recalled?

Yes. Becton Dickinson & recalled BD BBL Taxo XV Factor Strips on 22 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-0523-2013.

Why was it recalled?

In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.

Which lots are affected?

Lot number 2089253

Where was it sold?

Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico

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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