Z-2112-2013Class II

PrepStain Tecan US-II. For use in the screening and detection of cervical cancer

Name: Z-2112-2013 PrepStain Tecan US-II. For use in the screening and detection of cervical cancer
Creator: Becton Dickinson & Co.
Published: 2013-07-08
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-07-08 / Terminated / root cause: software

FDA source

Becton Dickinson & Co. began a recall of PrepStain Tecan US-II. For use in the screening and detection of cervical cancer on 2013-07-08. FDA classified it as Class II and gives the reason as "PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2112-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Posted: 2013-08-28
Terminated: 2014-05-01
Recalling firm: Becton Dickinson & Co
Product: PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
Product code: MKQ Processor, Cervical Cytology Slide, Automated
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.
Root cause tag: software
FDA root cause: Software design
Action: Ex-US BD sites were notified via email and teleconference, and will communicate directly with customer sites in their region as required by local regulation. All US customers were initially contacted via telephone and letters were mailed.
Quantity in commerce: 890 instruments
Distribution: Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
Product codes and lots: Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2112-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2110-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-28
Z-2111-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-28
Z-2112-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-28

Product code MKQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)