Z-2110-2013 Class II Terminated
FDA device recall Z-2110-2013 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 AG. 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 - 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2110-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026