Recall Z-1703-2015
Siemens Healthcare Diagnostics, Inc. · initiated March 25, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1703-2015
- Initiated
- March 25, 2015
- Posted by FDA
- June 2, 2015
- Terminated
- January 24, 2017
- Product code
- GFO – Activated Partial Thromboplastin
- Quantity
- 27501
- Distribution
- Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE