Z-1005-2010

Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ. The...

Name: Z-1005-2010 Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ. The...
Creator: Whatman, Inc.
Published: 2009-05-19
License: https://open.fda.gov/license/

Whatman, Inc. / initiated 2009-05-19 / Terminated / root cause: manufacturing process

FDA source

Whatman, Inc. began a recall of 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... on 2009-05-19. The reason FDA records is "'903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1005-2010
Status: Terminated
Initiated: 2009-05-19
Posted: 2010-03-05
Terminated: 2015-09-28
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.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: '903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results
Root cause tag: manufacturing process
FDA 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 in commerce: 11,300 Cards
Distribution: Nationwide Distribution -- CA.
Product codes and lots: Lot Number: W071, Job Numbers: 6797908 and 6820708.

Product code JKA

K932661Class IIWhatman Body Fluid Collection Paper:whatman Bfc180Whatman Specialty Products, Inc. / cleared 1996-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)