Recall Z-1462-2008
Abbott Laboratories · initiated January 21, 2008
Product
AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
Codes / lots: Lot Numbers: 59311P100 and 59312P100.
Reason for recall
Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.
FDA-determined cause: Software change control
Action taken
Consignees were sent a Product Correction-Immediate Action Required letter on 1/21/08. The letter provided users with the steps to take to temporarily correct the problem until the recalling firm is able to send a corrected assay file. 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-1462-2008
- Initiated
- January 21, 2008
- Posted by FDA
- May 14, 2008
- Terminated
- December 1, 2009
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Quantity
- 1,270 disks
- Distribution
- Worldwide Distribution including USA territory of Puerto Rico, and countries of Australia, Canada, Chile, Colombia, Germany, Mexico, New Zealand, South Korea, Taiwan, Thailand and Venezuela.
- Recalling firm
- Abbott Laboratories, Abbott Park, IL