Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays.
FDA device recall Z-0971-03 · posted 2003-07-02 · Terminated
Recall details
- Recalling firm
- PerkinElmer Life Sciences Inc
- Reason for recall
- The device is not stable throughout its labeled expiration date.
- Action taken
- The firm contacted their customers by telephone and facsimile on 5/30/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIA
- Quantity affected
- 42 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.
- Date initiated
- 2003-05-30
- Date posted
- 2003-07-02
- 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 |
|---|---|---|
| NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (K950481) | Isolab, Inc. | 1996-02-01 |