Recall Z-2325-2009
Abbott Laboratories · initiated April 24, 2009
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.
Codes / lots: Product List Number: 6E58 (US) Version 22.01and 6E59 (WW) Version 23.0 and lower, all serial numbers.
Reason for recall
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).
FDA-determined cause: Software change control
Action taken
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.
Details
- Recall number
- Z-2325-2009
- Initiated
- April 24, 2009
- Posted by FDA
- September 30, 2009
- Terminated
- November 30, 2009
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 1,037CD-ROMs - US, 4,676 CD-ROMs - WW
- Distribution
- Worldwide Distribution -- United States including Puerto Rico and Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay and Venezuela.
- Recalling firm
- Abbott Laboratories, Abbott Park, IL