Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103
FDA device recall Z-1140-03 · posted 2003-08-20 · Terminated
Recall details
- Recalling firm
- Perkinelmer Life Sciences, Inc.
- Reason for recall
- Product's outer carton label was labeled with an extended expiration date
- Action taken
- PerkinElmer notified customers by telephone on 7/21/2003 of the expiration date error on the outer carton label . A recall letter issued on 7/25/03 and a verification form was requested to be completed and returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- DHN
- Quantity affected
- 69 kits
- Distribution
- CA, PA, IN, MO Foreign: Switzerland
- Date initiated
- 2003-07-21
- Date posted
- 2003-08-20
- Date terminated
- 2003-11-19
- Location
- Boston, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON (K843347) | E.I. Dupont DE Nemours & Co., Inc. | 1984-10-05 |