Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
FDA device recall Z-1374-05 · posted 2005-08-16 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- Reason for recall
- sample may exhibit falsely high results
- Action taken
- On 7/13/05, the recalling firm issued letters to their customers informing them of the problem and the need to discontinue use and to discard any remaining product.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJT
- Quantity affected
- 3255 packs
- Distribution
- The product was shipped to medical facilities and laboratories in AR, AZ, CA, FL, GA, ID, IL, IN, KS, KY, MA, MD, NC, ND, NV, NY, OH, OK, PA, TX, VA, WA, WI, and WV. The products were also shipped to
- Date initiated
- 2005-07-08
- Date posted
- 2005-08-16
- Date terminated
- 2006-08-10
- 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 |
|---|---|---|
| CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA (K924396) | Behring Diagnostics, Inc. | 1993-05-21 |