Class 2 Device Recall Clinical Chemistry Iron/Magnesium Calibrator

• Date Initiated by Firm: April 24, 2008
• Date Posted: February 06, 2009
• Recall Status: Terminated on July 09, 2009
• Recall Number: Z-0950-2009
• Recall Event ID: 48172
• 510(K)Number: K981706
• Product Classification: Multi-Analyte Mixture Calibrator - Product Code JIX
• Product: Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03, Lot Numbers: 54187M200; ; For use in the calibration of the Iron and Magnesium assays.
• Code Information: Lot Number: 54187M200
• Recalling Firm/ Manufacturer: Abbott Laboratories Inc.; 820 Mission St; South Pasadena CA 91030-3142
• For Additional Information Contact: 626-440-0705
• Manufacturer Reason for Recall: An incorrect Magnesium calibrator 2 value (CAL 2) was provided for Clinical Chemistry Iron/Magnesium Calibrator lot number 54187M200. Use of the incorrect Magnesium CAL 2 value causes quality control and patient magnesium results to be reduced by as much as 17.24% above 0.8mEq/L (1.0 mg/dL or 0.4 mmol/L).
• FDA Determined Cause: Error in labeling
• Action: On April 24, 2008, a Product Correction letter with attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. Customer reply form were included in all US customers letter. The letter instructed customers to: 1. Identify the lot number of Clinical Chemistry Iron/Magnesium Calibrator currently used in your laboratory 2. If you have lot number 54187M200, cross out the incorrect Magnesium CAL 2 value in the value sheet, commodity 30-3535/R1, June 2005. Place a copy of this letter in all calibrator kits with this lot number. 3. Enter the revised Magnesium CAL 2 value provided in this letter in your system. NOTE: Ensure that the value used corresponds to the units of concentration used in your laboratory. *ARCHITECT cSystems - Refer to Enter a calibrator concentration (cSystem) in Section 2, Installation procedures and special requirements of the ARCHITECT System Operations Manual. *AEROSET - Refer to Calibrator/Control Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual. 4. Calibrate the Magnesium assay. Verify the calibration with at least two levels of controls according to the established quality control requirement for your laboratory. Customers were also instructed to please retain this communication for future reference and if they have forwarded any Clinical Chemistry Iron/Magnesium Calibrator to another laboratory, please provide a copy of this letter to them. An 800 number was provided in the recall letter for any questions the affected customers or any of the health care providers they serve may have.
• Quantity in Commerce: 1287
• Distribution: Worldwide Distribution --- USA including states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, and WI, and countries of Mexico, Chile, Puerto Rico, Canada, Thailand, Curacao, Guatemala, Argentina, Dominican Republic, Germany, New Zealand, Jamaica, Ecuador, Brazil, El Salvador, Hong Kong, and Bermuda.
• 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 = JIX and Original Applicant = ABBOTT LABORATORIES