Class 3 Device Recall ARCHITECT STAT Myoglobin Calibrators

• Date Initiated by Firm: October 17, 2005
• Date Posted: January 18, 2006
• Recall Status: Terminated on May 25, 2006
• Recall Number: Z-0400-06
• Recall Event ID: 33845
• 510(K)Number: K042920
• Product Classification: Myoglobin, Antigen, Antiserum, Control - Product Code DDR
• Product: ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
• Code Information: list 02K43-01, lot number V96128
• Recalling Firm/ Manufacturer: Abbott Laboratories MPG; 100 Abbott Park Rd; Abbott Park IL 60064-3502
• For Additional Information Contact: Customer Support Center; 877-422-2688
• Manufacturer Reason for Recall: Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen.
• FDA Determined Cause: Other
• Action: Abbott telephoned the laboratory end users on 10/17/05, informing them that Abbott discovered that ARCHITECT STAT Myoglobin Calibrators, lot V96128, were shipped to their facilities using the incorrect shipping conditions between August 29th and September 20th 2005. The kits should have been shipped frozen, but were shipped ambient. The error has been corrected. All shipments made after September 21, 2005 have been shipped correctly. Any data generated to date using this kit of calibrators is acceptable, providing that a valid calibration was achieved and product labeling was followed. However, long term use of this kit may result in calibration failures or controls out of range. The accounts were requested to mark the kit(s) of this lot currently in inventory to distinguish them from the replacement kit(s) Abbott will be sending to them. As a precaution, Abbott requested the labs to discontinue use of these kits and destroy them the replacement kits are received.
• Quantity in Commerce: 11 kits
• Distribution: Texas, Washington, Montana, Pennsylvania and Kentucky, and internationally to Korea
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DDR