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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Laboratories Inc.
Lot Codes / Batch Numbers
Lot Number: 54187M200
Products Sold
Lot Number: 54187M200
Abbott Laboratories Inc. is recalling Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03, Lot Numbers: due to An incorrect Magnesium calibrator 2 value (CAL 2) was provided for Clinical Chemistry Iron/Magnesium Calibrator lot number 54187M200. Use of the inco. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CT, FL, GA, IL, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, PR
Page updated: Jan 10, 2026