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U.S. Department of Health and Human Services

Class 3 Device Recall ARCHITECT STAT Myoglobin Calibrators

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  Class 3 Device Recall ARCHITECT STAT Myoglobin Calibrators see related information
Date Initiated by Firm October 17, 2005
Date Posted January 18, 2006
Recall Status1 Terminated 3 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/
Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Customer Support Center
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 2
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 and Original Applicant = HOVEROUND CORP.