CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report

PrepStain AG recalled by Becton Dickinson &

Becton Dickinson & is recalling PrepStain AG, distributed nationwide in the US. The recall was initiated on 8 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Numbers - 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R

Quantity recalled890 instruments

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-2110-2013
FDA event ID: 65779
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 8 Jul 2013
FDA classified: 28 Aug 2013
Reported: 4 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Jul 2013	Recall initiated by company
28 Aug 2013	Classified by FDA	+51 days
4 Sep 2013	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

PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

Product as listed by the FDA

PrepStain AG. For use in the screening and detection of cervical cancer.

Where it was distributed

Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.

Nationwide Puerto Rico

Questions about this recall

Is PrepStain AG recalled?

Yes. Becton Dickinson & recalled PrepStain AG on 8 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-2110-2013.

Why was it recalled?

PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

Which lots are affected?

Catalog Numbers - 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R

Where was it sold?

Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.

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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