Recall Z-1703-2015 ยท GFO Activated Partial Thromboplastin
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Jun 2, 2015 (initiated Mar 25, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 27501 |
| Distribution | Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K760318 | ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT Dade, Baxter Travenol Diagnostics, Inc., Aug 3, 1976 |