PrepStain AG — Class II medical device recall Z-2110-2013
Terminated recall by Becton Dickinson & Co., reported 2013-09-04, distributed nationwide. PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive main
| Recall number | Z-2110-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2013-07-08 |
| Classified | 2013-08-28 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 890 instruments |
| Model numbers | 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2110-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.