Recall Z-0950-2009 ยท JIX Calibrator, Multi-Analyte Mixture
Abbott Laboratories Inc.
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.
| Date | Feb 6, 2009 (initiated Apr 24, 2008) |
| Status | Terminated |
| Reason | 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). |
| Root 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981706 | AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 Abbott Laboratories, Jul 9, 1998 |