Class 2 Device Recall PerkinElmer Life Sciences

• Date Initiated by Firm: July 28, 2003
• Date Posted: September 12, 2003
• Recall Status: Terminated on November 19, 2003
• Recall Number: Z-1206-03
• Recall Event ID: 26852
• 510(K)Number: K850054
• Product Classification: Radioimmunoassay, Angiotensin I And Renin - Product Code CIB
• Product: Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube; Catalog Number: NEA104; For in-vitro diagnostic use
• Code Information: Lot 181269, Expiration 8/27/03
• Recalling Firm/ Manufacturer: Perkinelmer Life Sciences, Inc.; 549 Albany Street; Boston MA 02118
• For Additional Information Contact: Jeannette Potwin; 617-350-9212
• Manufacturer Reason for Recall: Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
• FDA Determined 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 in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CIB and Original Applicant = E.I. DUPONT DE NEMOURS & CO., INC.