Recall Z-0898-03 ยท JJT Enzyme Controls (Assayed And Unassayed)
PerkinElmer LIfe Sciences Inc
Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
| Date | May 29, 2003 (initiated Jan 8, 2003) |
| Status | Terminated |
| Reason | The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed. |
| Root cause | Other |
| Action | The firm notified their customers by letter on 1/8/2003. |
| Quantity | 75 Kits |
| Distribution | The kits were shipped to three (3) State Departments of Health in WI, AR, and MI. |
| 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 |