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Terminated

Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.

FDA Recall Z-0970-03 · Posted 2003-07-02

Recalling FirmPerkinElmer Life Sciences Inc
Recall StatusTerminated
Product CodeJIA
Date Initiated2003-05-30
Date Terminated2008-10-24
Product Quantity91 kits

Reason for Recall

The device is not stable throughout its labeled expiration date.

Firm Action

The firm contacted their customers by telephone and facsimile on 5/30/2003.

Root Cause

Other

Distribution Pattern

Nationwide. The product was also shipped to foreign distributors and end-users located in Brazil, Costa Rica, Mexico, Finland, Venezuela, Taiwan, and Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITIsolab, Inc. · 1996-02-01

Official Source

View FDA Recall →

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

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