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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Whatman, Inc.
Lot Codes / Batch Numbers
Lot Number: W071, Job Numbers: 6797908 and 6820708.
Products Sold
Lot Number: W071, Job Numbers: 6797908 and 6820708.
Whatman, Inc. is recalling Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ. due to '903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
'903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026