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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM Folate Reagent Pack

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  Class 2 Device Recall AxSYM Folate Reagent Pack see related information
Date Initiated by Firm January 19, 2009
Date Posted April 15, 2009
Recall Status1 Terminated 3 on September 11, 2010
Recall Number Z-1049-2009
Recall Event ID 50816
510(K)Number K972232  
Product Classification Folic Acid Radioimmunoassay - Product Code CGN
Product AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma or red blood cells on the AxSYM System; list 3C81-20
Code Information lot 68537M100
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall		 Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
FDA Determined
Cause 2		 Employee error
Action Consignees were sent a Product Correction-Immediate Action Required letter on 1/19/09. The letter informed users of the reported increased frequency of probe crashes when using the affected reagent pack lots and provided instructions on what actions the laboratory can take if they have a defective reagent pack or experience a probe crash with their system. Users need to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading reagent pack on instrument; and discard any reagent packs that do not open properly. If a probe crash is observed prior to testing samples again, a probe crash recovery must be performed following the procedure in the Operations Manual. A copy of the communication needs to be provided to any laboratory that you may have forwarded affected lots to. Users were requested to return a customer reply letter acknowledging receipt and understanding of the letter. For additional information, contact Abbott Labs at 1-877-4ABBOTT.
Quantity in Commerce 1,142 kits
Distribution Worldwide Distribution -- USA including Puerto Rico and countries of Germany, Mexico, Hong Kong, and Japan.
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 = CGN and Original Applicant = ABBOTT LABORATORIES
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