Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
FDA device recall Z-0898-03 · posted 2003-05-29 · Terminated
Recall details
- Recalling firm
- PerkinElmer LIfe Sciences Inc
- Reason for recall
- The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.
- Action taken
- The firm notified their customers by letter on 1/8/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJT
- Quantity affected
- 75 Kits
- Distribution
- The kits were shipped to three (3) State Departments of Health in WI, AR, and MI.
- Date initiated
- 2003-01-08
- Date posted
- 2003-05-29
- Date terminated
- 2008-09-13
- 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 |