Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube Catalog Number: NEA105 For in-vitro diagnostic use
FDA device recall Z-1207-03 · posted 2003-09-12 · Terminated
Recall details
- Recalling firm
- Perkinelmer Life Sciences, Inc.
- Reason for recall
- Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
- Action taken
- PerkinElmer notified all customers who received the lots by telephone by July 23, 2003 followed by letter dated July 25, 2003, which includes instructions for documenting receipt and lot removal either by destroying or returning product to PerkinElmer
- Root cause
- Other
- Status
- Terminated
- Product code
- CIB
- Quantity affected
- 48 Kits
- Distribution
- MD, NC, CA, VT, IL, MI, IL, NY, DC, MN, HI, WA, UT Nationwide. International: Belgium, Germany, Israel, UK, Canada, Hugary, Switzerland, Korea
- Date initiated
- 2003-07-28
- Date posted
- 2003-09-12
- 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 ANGIOTENSIN I RADIOIMMUNOASSAY KI (K850054) | E.I. Dupont DE Nemours & Co., Inc. | 1985-03-29 |