VITROS Chemistry Products VANC Reagent — Class II medical device recall Z-1887-2017
Terminated recall by Ortho-Clinical Diagnostics, reported 2017-05-03, distributed in PR. Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after th
| Recall number | Z-1887-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2017-02-21 |
| Classified | 2017-04-27 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2019-06-19 |
| Distributed | PR |
| Countries outside the US | AU, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, PL, SG, VE |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10758750006731 |
| Lot numbers | 31-5407 |
| Expiration dates | 2017-05-23, 2017-07-04 |
Product
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
Reason for recall
Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.
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-1887-2017. 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.