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U.S. Department of Health and Human Services

Class 3 Device Recall Abbott Commander Flexible Pipetting Center (FPC) Operations Manual

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  Class 3 Device Recall Abbott Commander Flexible Pipetting Center (FPC) Operations Manual see related information
Date Initiated by Firm December 02, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 20, 2004
Recall Number Z-0297-04
Recall Event ID 27898
510(K)Number K894069  
Product Classification unknown device name - Product Code JQW--
Product Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott Laboratories, Abbott Park, IL 60064
Code Information all revision numbers, all versions
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information Contact Abbott Customer Service
877-422-2688
Manufacturer Reason
for Recall		 The Operations Manual has the wrong Farenheit temperature range listed (102-122) instead of (104-122) for the preparation of the Terg-A-Zyme solution used to clean pipettes of the Abbott Commander Flexible Pipetting Center.
FDA Determined
Cause 2		 Other
Action Abbott sent 'Important Product Information' letters dated 12/2/03 to the end user accounts, advising them of the error in conversion of the Celsius temperature range to Farenheit in the first step in preparing the Terg-A-Zyme cleaning solution. The letter listed the entire corrected solution preparation procedure and advised the accounts to retain the letter with the Abbott FPC Operations Manual for future reference.
Distribution Nationwide and internationally through Abbott affiliates in Colombia, Brazil, Puerto Rico, Japan, Singapore, Hong Kong and Germany.
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 = JQW-- and Original Applicant = ABBOTT LABORATORIES
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