BCS — Class II medical device recall Z-1867-2012
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2012-07-04, distributed nationwide. Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay u
| Recall number | Z-1867-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2010-12-01 |
| Classified | 2012-06-25 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2014-03-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, DE, ES, FR, GR, HR, IT, NL, SA, SI, TR |
| Quantity | 186 |
| Reason classes | potency |
| Model numbers | OVIO03 |
Product
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
Reason for recall
Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT based clotting assay several results may be shortened.
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-1867-2012. 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.