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Terminated

Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.

FDA Recall Z-1499-04 · Posted 2004-09-30

Recalling FirmPerkinElmer LAS Inc
Recall StatusTerminated
Product CodeJIA
Date Initiated2004-09-08
Date Terminated2008-10-29
Product Quantity49 kits

Reason for Recall

There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the specified range.

Firm Action

The firm contacted their consignees by letter sent 9/8/04.

Root Cause

Other

Distribution Pattern

The kits were distributed to 5 consignees, located in Indianapolis, IN; Jefferson City, MO; Austin, TX; Madison, WI; and Minneapolis, MN.

Official Source

View FDA Recall →

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

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