Class 3 Device Recall IMMAGE CReactive Protein (CRP) Reagent

• Date Initiated by Firm: January 10, 2008
• Date Posted: March 02, 2010
• Recall Status: Terminated on July 02, 2012
• Recall Number: Z-0921-2010
• Recall Event ID: 48648
• 510(K)Number: K981638
• Product Classification: C-Reactive Protein Antigen, Antiserum, and Control - Product Code DCK
• Product: IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280. Intended for the quantitative determination of C-Reactive Protein (CRP) in human serum or plasma by rate nephelometry.
• Code Information: Lots M705441, M709279, M709319
• FEI Number: 2050012
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 S Kraemer Blvd; Brea CA 92822-6208
• For Additional Information Contact: 714-993-5321 Ext. 8383
• Manufacturer Reason for Recall: IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples with extremely high CRP analyte concentration.
• FDA Determined Cause: Other
• Action: Customers were sent Urgent: Product Corrective Action letters dates, 1/22/2008. The letter identified the issue, discussed the impact, and listed the following actions/resolution. * To eliminate the hook effect when using these lots, run CRP samples beginning with the 1:216 dilution. ~ A limited correlation of patient samples run in the 1:36 dilution compared to the same samples run in the 1:216 dilution verifies acceptable performance (there may be a shift of up to 0.8 mg/dL for samples between 1.0 and 8.0 mg/dL). * Controls run in the 1:216 dilution may recover differently than those run in the default 1:36 dilution. A limited number of control samples were also run in the 1:216 dilution. * The IMMAGE 800 system can be set to default to a non-standard dilution for each chemistry. Change CRP to a Non-Standard Dilution of 1:216 in the Setup section of the software. Detailed instructions for configuring a Non-Standard dilution as default are located in chapter 5 of the IMMAGE 800 Immunochemistry System Operations Manual. * The IMMAGE system does not allow resetting the default dilution of a chemistry. Instructions for running CRP samples beginning in a Non-Standard Dilution are enclosed. * Complete and return the enclosed response form within 10 days so we may maintain our records. Customers are to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. Questions regarding this letter should be directed to 800-854-3633 or customers can contact their local Beckman Coulter Representative
• Quantity in Commerce: 878 kits
• Distribution: Nationwide Distribution -- Including states of AL, CA, CT, DC, FL, FL ,GA, HI, IA, IL ,IN, KY ,MA, MD, ME, MI, MO, NE, NJ, NY, OH, OR, PA, RI, TX, VA, WI, and WV.
• 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 = DCK