Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-410
FDA device recall Z-1139-03 · posted 2003-08-20 · Terminated
Recall details
- Recalling firm
- PerkinElmer Life Sciences Inc
- Reason for recall
- The kits are producing lower values than expected, which may result in an increase of false positive test results.
- Action taken
- The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03.
- Root cause
- Other
- Status
- Terminated
- Product code
- JLJ
- Quantity affected
- 85 kits
- Distribution
- The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH.
- Date initiated
- 2003-06-27
- Date posted
- 2003-08-20
- Date terminated
- 2008-10-24
- Location
- Norton, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE (K950803) | Isolab, Inc. | 1995-09-21 |