Recall Z-1206-03 ยท CIB Radioimmunoassay, Angiotensin I And Renin
Perkinelmer Life Sciences, Inc.
Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use
| Date | Sep 12, 2003 (initiated Jul 28, 2003) |
| Status | Terminated |
| Reason | Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples |
| Root cause | Other |
| Action | 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 |
| Quantity | 29 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850054 | RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI E.I. Dupont DE Nemours & Co., Inc., Mar 29, 1985 |