Recall Z-1005-2010 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Whatman, Inc.
Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ. The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood.
| Date | Mar 5, 2010 (initiated May 19, 2009) |
| Status | Terminated |
| Reason | '903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results |
| Root cause | Process control |
| Action | Whatman issued an "Urgent Medical Device Correction " letter on May 19, 2009. The consignee was instructed to remove cards with duplicate numbers. For further information, contact Whatman Inc. Quality Assurance at 1-207-459-7557. |
| Quantity | 11,300 Cards |
| Distribution | Nationwide Distribution -- CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932661 | WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 Whatman Specialty Products, Inc., Apr 17, 1996 |