RecallDepth

Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000

Company
Perkin Elmer Life And Analytical Sciences Inc
Recall Initiated
January 9, 2004
Posted
July 20, 2004
Terminated
October 29, 2008
Recall Number
Z-0514-04
Quantity
333 kits
Firm Location
Norton, OH

Reason for Recall

The device is not stable throughout its labeled expiration date.

Distribution

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.

Lot / Code Info

Lots #177835, Exp 1/7/04; #178068, Exp 2/7/04; #195324, Exp 2/18/04; #204423, Exp 4/8/04; #207440, Exp 4/29/04; #213466, Exp 5/24/04.

Root Cause

Other

Action Taken

The firm contacted their customers by letter on 1/9/2004.

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