Dade — Class II medical device recall Z-1073-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-04-17, distributed nationwide. Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life w
| Recall number | Z-1073-2013 |
|---|---|
| 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 | 2013-03-11 |
| Classified | 2013-04-09 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 13,083 |
| Lot numbers | 547311, 547312, 547316A |
| Model numbers | B4219-1, B4219-2 |
| Expiration dates | 2013-03-22, 2013-04-28 |
Product
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Reason for recall
Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
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-1073-2013. 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.