Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determina
FDA device recall Z-1703-2015 · posted 2015-06-02 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GFO
- Quantity affected
- 27501
- Distribution
- Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.
- Date initiated
- 2015-03-25
- Date posted
- 2015-06-02
- Date terminated
- 2017-01-24
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT (K760318) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-08-03 |