Z-1090-2009

BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00...

Name: Z-1090-2009 BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00...
Creator: Bd Diagnostic Systems Tripath
Published: 2008-09-26
License: https://open.fda.gov/license/

BD Diagnostic Systems Tripath / initiated 2008-09-26 / Terminated / root cause: software

FDA source

Bd Diagnostic Systems Tripath began a recall of BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog... on 2008-09-26. The reason FDA records is "Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results". 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-1090-2009
Status: Terminated
Initiated: 2008-09-26
Posted: 2009-03-19
Terminated: 2013-01-15
Recalling firm: BD Diagnostic Systems Tripath
Product: BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage.
Product code: MKQ Processor, Cervical Cytology Slide, Automated
Reason for recall: Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.
Root cause tag: software
FDA root cause: Software change control
Action: BD Diagnostics began contacting known non-gyn customers by phone on 09/26/2008. Customers were notified by Urgent - Important Product Information letter on 09/29/2008. They were advised to stop using the system until they complete a list of actions provided in the letter. A telephone contact number for Technical Support was provided in the letter. A permanent software based solution will be provided to customers when completed. They anticipate the software will be available in October 2008.
Quantity in commerce: 662 units
Distribution: Worldwide Distribution
Product codes and lots: GYN software version 1.2, Non-GYN version 2.80; GYN software version 1.3.0.1, Non-GYN software version 2.80.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)