FDA Device recall Z-1703-2015
Dade Actin Activated Cephaloplastin Reagent
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of Dade Actin Activated Cephaloplastin Reagent by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1703-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-25 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | PR |
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
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.
Identifiers
| code_info | Catalog Number B4218-1, Material Number 10445709, lot numbers 557128, 557129, 557130, 557131, 557132, 557133, 557134,…Catalog Number B4218-1, Material Number 10445709, lot numbers 557128, 557129, 557130, 557131, 557132, 557133, 557134, 557135, 557140, 557141 , expiration dates:10/31/2015, 11/21/2015, 2/16/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1703-2015%22
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