Recall Z-0514-04 ยท JIA Enzymatic Methods, Galactose
Perkin Elmer Life and Analytical Sciences Inc
Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000
| Date | Jul 20, 2004 (initiated Jan 9, 2004) |
| Status | Terminated |
| Reason | The device is not stable throughout its labeled expiration date. |
| Root cause | Other |
| Action | The firm contacted their customers by letter on 1/9/2004. |
| Quantity | 333 kits |
| 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. |
| 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 |