FDA Device recall Z-2110-2013
PrepStain AG. For use in the screening and detection of cervical cancer
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of PrepStain AG. For use in the screening and detection of cervical cancer by Becton Dickinson And, citing prepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2110-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-08 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
PrepStain AG. For use in the screening and detection of cervical cancer.
Reason
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
Identifiers
| code_info | Catalog Numbers - 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2110-2013%22
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