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.
Recall
- Recall Number
- Z-1703-2015
- Event Number
- 71273
- Firm
- Siemens Healthcare Diagnostics, Inc.
- FEI Number
- 2517506
- Product Code
- GFO
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- March 25, 2015
- Posted
- June 2, 2015
- Terminated
- January 24, 2017
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466
Description
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.
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.
On March 24, 2015 an Urgent Medical Device Recall letter was mailed to all affected customers to notify them about the issue, associated risks, and actions to be taken.
Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.
27501