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Terminated

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.

FDA Recall Z-1005-2010 · Posted 2010-03-05

Recalling FirmWhatman, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2009-05-19
Date Terminated2015-09-28
Product Quantity11,300 Cards

Reason for Recall

'903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution -- CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932661WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180Whatman Specialty Products, Inc. · 1996-04-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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