Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000
FDA device recall Z-0515-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Perkin Elmer Life and Analytical Sciences Inc
- Reason for recall
- The device is not stable throughout its labeled expiration date.
- Action taken
- The firm contacted their customers by letter on 1/9/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIA
- Quantity affected
- 178 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.
- Date initiated
- 2004-01-09
- Date posted
- 2004-07-20
- Date terminated
- 2008-10-29
- 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 |