Z-2112-2013 Class II Terminated
FDA device recall Z-2112-2013 was initiated by Becton Dickinson & Co. on Jul 8, 2013 and is designated Class II. 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. The recall status is terminated (terminated May 1, 2014). Affected quantity: 890 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 4, 2013
- Initiation Date
- Jul 8, 2013
- Termination Date
- May 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 890 instruments
Product Description
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
Code Information
Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2112-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026