Recall Z-1139-03 ยท JLJ Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
PerkinElmer Life Sciences Inc
Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
| Date | Aug 20, 2003 (initiated Jun 27, 2003) |
| Status | Terminated |
| Reason | The kits are producing lower values than expected, which may result in an increase of false positive test results. |
| Root cause | Other |
| Action | The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03. |
| Quantity | 85 kits |
| Distribution | The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE Isolab, Inc., Sep 21, 1995 |