Abbott Laboratories ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Abbott Laboratories, Diagnostic Division, Abbott Park, IL 60064 USA; Product List Number: 6E58 (US) and 6E59 (WW) Versions 23 and lower. The Architect LH assay is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of human luteinizing hormone (LH) in human serum or plasma. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Abbott Laboratories, Diagnostic Division, Abbott Park, IL 60064 USA; Product List Number: 6E58 (US) and 6E59 (WW) Versions 23 and lower. The Architect LH assay is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of human luteinizing hormone (LH) in human serum or plasma.
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
Product List Number: 6E58 (US) Version 22.01and 6E59 (WW) Version 23.0 and lower, all serial numbers.
Products Sold
Product List Number: 6E58 (US) Version 22.01and 6E59 (WW) Version 23.0 and lower, all serial numbers.
Abbott Laboratories is recalling ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-R due to There continues to be an elevated level of complaint activity for calibration error code 1227, when using ARCHITECT LH reagent lots (6C25-22 or 6C25-2. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There continues to be an elevated level of complaint activity for calibration error code 1227, when using ARCHITECT LH reagent lots (6C25-22 or 6C25-27) due to the use of assay disk versions that do not contain the updated ARCHITECT LH assay file contained on ARCHITECT i System Assay CD ROM versions 24 and higher (US LN 6E58, WW LN 6E59).
Recommended Action
Per FDA guidance
Abbott issued a "Product Correction-Immediate Action Required" letter dated April 24, 2009. The letter provided users with the steps to take to determine what version of the ARCHITECT LH Assay is on their instrument and instructions for installing the assay file provided with the letter if needed. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.
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 noticePage updated: Jan 10, 2026