Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (A
FDA device recall Z-1073-2013 · posted 2013-04-09 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
- Action taken
- Siemens sent an "URGENT FIELD SAFETY NOTICE" dated February 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The safety notice instructed consignees to discontinue use of the affected lots and discard any remaining inventory. Contact the firm at 1-800-242-3233, option 1 for questions about this notice.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- GGW
- Quantity affected
- 13,083
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NJ, NM, NV, NY,
- Date initiated
- 2013-03-11
- Date posted
- 2013-04-09
- Date terminated
- 2013-12-24
- Location
- Newark, DE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACTIN FSL ACTIVATED PTT REAGENT (K863594) | American Dade | 1986-10-17 |