Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000
FDA Recall Z-0515-04 · Posted 2004-07-20
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Recalling FirmPerkin Elmer Life and Analytical Sciences Inc
Recall StatusTerminated
Product CodeJIA
Date Initiated2004-01-09
Date Terminated2008-10-29
Product Quantity178 kits
Reason for Recall
The device is not stable throughout its labeled expiration date.
Firm Action
The firm contacted their customers by letter on 1/9/2004.
Root Cause
Other
Distribution Pattern
The kits were shipped to domestic end-users located in NJ, PA, TX, IN, MI, MO, IL, CO, CT, AR, FL, LA, OH, NM, WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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