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Terminated

Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.

FDA Recall Z-1139-03 · Posted 2003-08-20

Recalling FirmPerkinElmer Life Sciences Inc
Recall StatusTerminated
Product CodeJLJ
Date Initiated2003-06-27
Date Terminated2008-10-24
Product Quantity85 kits

Reason for Recall

The kits are producing lower values than expected, which may result in an increase of false positive test results.

Firm Action

The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03.

Root Cause

Other

Distribution Pattern

The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH.

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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