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Terminated

Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.

FDA Recall Z-0898-03 · Posted 2003-05-29

Recalling FirmPerkinElmer LIfe Sciences Inc
Recall StatusTerminated
Product CodeJJT
Date Initiated2003-01-08
Date Terminated2008-09-13
Product Quantity75 Kits

Reason for Recall

The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.

Firm Action

The firm notified their customers by letter on 1/8/2003.

Root Cause

Other

Distribution Pattern

The kits were shipped to three (3) State Departments of Health in WI, AR, and MI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEIsolab, Inc. · 1995-09-21

Official Source

View FDA Recall →

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

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