FDA Device recall Z-2112-2013
PrepStain Tecan US-II. 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 Tecan US-II. 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-2112-2013 |
| 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 Tecan US-II. 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 - 799-14000-00 (490100) and 799-14000-00R (490407) |
|---|
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-2112-2013%22
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