Dade Actin Activated Cephaloplastin Reagent — Class II medical device recall Z-1703-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-06-10, distributed in PR. Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >
| Recall number | Z-1703-2015 |
|---|---|
| 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 | 2015-03-25 |
| Classified | 2015-06-02 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2017-01-24 |
| Distributed | PR |
| Countries outside the US | BB, MX |
| Quantity | 27,501 |
| Lot numbers | 557128, 557129, 557130, 557131, 557132, 557133, 557134, 557135, 557140, 557141 |
| Model numbers | B4218-1 |
| Expiration dates | 2015-10-31 |
Product
Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.
Reason for recall
Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recoveries close to the medical decision points could exhibit a deviation up to 4 seconds for the normal range and up to 33% for the pathological range.
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-1703-2015. 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.