Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000
- Recall Initiated
- January 9, 2004
- Posted
- July 20, 2004
- Terminated
- October 29, 2008
- Recall Number
- Z-0515-04
- Quantity
- 178 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 #178052, Exp 2/7/04; #182567, Exp 1/7/04; #195339, Exp 2/18/04; #207487, Exp 4/29/04.
Root Cause
Other
Action Taken
The firm contacted their customers by letter on 1/9/2004.