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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT 25OH Vitamin D Reagent Kit

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 Class 2 Device Recall ARCHITECT 25OH Vitamin D Reagent Kitsee related information
Date Initiated by FirmDecember 12, 2012
Date PostedJanuary 23, 2013
Recall Status1 Terminated 3 on December 23, 2016
Recall NumberZ-0698-2013
Recall Event ID 63912
510(K)NumberK110619 
Product Classification System test Vitamin d - Product Code MRG
ProductAbbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.
Code Information ARCHITECT 25-OH Vitamin D Reagent Kit list 3L52, lot numbers 02412C000, exp. 12/26/2012; 02512C000, exp. 12/26/2012; 02012G000, exp. 7/16/2013; 01612G000, exp. 7/17/13; 00912G000, exp. 7/10/13; 02512I000, exp. 10/8/2013; 02612I000, exp. 10/8/2013; 03512I000, exp. 10/10/2013; 03712I000, exp. 10/10/13; when used with ARCHITECT Reaction Vessel (RV) list 7C15-01, box lot numbers (bag lot numbers): 19320P100 (6F9891501); 19344P100 (4N5891091); 19404P100 (1J1948151);  19322P100 (LM3891731); 19373P100 (6F9891521); 19407P100 (4N5948361); 19324P100 (NK8891921); 19374P100 (JG7891631); 19408P100 (5P4948471); 19340P100 (1J1890911); 19375P100 (LM3891741); 19497P100 (2L2948281); 19341P100 (2L2891001); 19379P100 (NK8891931); 20026P100 (LM3947841) 
Recalling Firm/
Manufacturer
Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information ContactCustomer Service
877-422-2788
Manufacturer Reason
for Recall
The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.
FDA Determined
Cause 2
Mixed-up of materials/components
ActionAbbott Laboratories sent a "Product Correction Immediate Action Required" letter dated December 12, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to immediately discontinue use and destroy any remaining inventory of the reaction vessel lots listed; to clear the ARCHITECT RV hopper of impacted RV lots following the instructions provided, prior to continued use of the ARCHITECT 25-OH Vitamin D assay; to review the patient results obtained with the affected lots with the treating physician or heath care provider to ensure they are aware of the potential analytical issue and can determine whether re-evaluation of the patient is necessary; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; and to retain a copy of the letter for their records and to complete and return the Customer Reply Form via fax to: 1-800-777-0051 For further questions please call your local Customer Service representative at 877-422-2688.
Quantity in Commerce28,600 total
DistributionWorldwide Distribution -- USA (nationwide) and the countries of Austria, Barbados, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Latvia, Libya, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MRG
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