Whatman, Inc. Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790
Brand
Whatman, Inc.
Lot Codes / Batch Numbers
Lot: W 071 6820708
Products Sold
Lot: W 071 6820708
Whatman, Inc. is recalling Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are i due to Neonate newborn screening card demographic and filter portion may be detached. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Neonate newborn screening card demographic and filter portion may be detached
Recommended Action
Per FDA guidance
The firm, Whatman, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 29, 2009, to the customer. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: inspect the card and ensure the 903 Paper Portion is firmly and completely fixed to the Demographic portio, prior to recording patient demographic details on the card and obtaining a patient sample; discard the card, obtain a new card and inspect as above, if the 903 Paper Portion of the card partially or completely detaches from the Demographic portion of the card; and to please staple the card stub at two points as specified in the illustration, to prevent any opportunity for 903 paper detachment from the demographic portions. If Whatman customers/users have any questions in relation to this customer notification, please contact, either Product Manager at +1 732 885 6570,email: lili.lee@ge.com or Quality Assurance at +1 207 459 7557, email: heidi.kuell@ge.com.
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