Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
This recall has been terminated (originally issued August 20, 2003).
- Company
- Perkinelmer Life Sciences Inc
- Recall Initiated
- June 27, 2003
- Posted
- August 20, 2003
- Terminated
- October 24, 2008
- Recall Number
- Z-1139-03
- Quantity
- 85 kits
- Firm Location
- Norton, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The kits are producing lower values than expected, which may result in an increase of false positive test results.
Distribution
The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH.
Lot / Code Info
Lot #164738
Root Cause
Other
Action Taken
The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03.
More recalls by Perkinelmer Life Sciences Inc
Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.
Jul 2, 2003