FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1005-2010
- Recalling firm
- Whatman, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-05-19
- Posted
- 2010-03-05
- Terminated
- 2015-09-28
- 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.
- Lot, serial or model codes
- Lot Number: W071, Job Numbers: 6797908 and 6820708.
- 510(k) numbers
- K932661
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 1281317
- Firm city
- Sanford
- Firm state
- ME
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28