—#114995

Product

Abbott 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.

FDA product code: MRG — System, Test, Vitamin D
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K110619
Affected lot / code info: 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)

Why it was recalled

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Abbott 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.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: Worldwide 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.

Timeline

Recall initiated: 2012-12-12
Posted by FDA: 2013-01-23
Terminated: 2016-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114995. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.