Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ. The device is used
FDA device recall Z-1005-2010 · posted 2010-03-05 · Terminated
Recall details
- Recalling firm
- Whatman, Inc.
- Reason for recall
- '903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 11,300 Cards
- Distribution
- Nationwide Distribution -- CA.
- Date initiated
- 2009-05-19
- Date posted
- 2010-03-05
- Date terminated
- 2015-09-28
- Location
- Sanford, ME
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 (K932661) | Whatman Specialty Products, Inc. | 1996-04-17 |