Recall Z-0970-03 ยท JIA Enzymatic Methods, Galactose
PerkinElmer Life Sciences Inc
Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.
| Date | Jul 2, 2003 (initiated May 30, 2003) |
| Status | Terminated |
| Reason | The device is not stable throughout its labeled expiration date. |
| Root cause | Other |
| Action | The firm contacted their customers by telephone and facsimile on 5/30/2003. |
| Quantity | 91 kits |
| Distribution | Nationwide. The product was also shipped to foreign distributors and end-users located in Brazil, Costa Rica, Mexico, Finland, Venezuela, Taiwan, and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT Isolab, Inc., Feb 1, 1996 |