Z-0698-2013Class II

Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100...

Name: Z-0698-2013 Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100...
Creator: Abbott Laboratories
Published: 2012-12-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-12-12 / Terminated

FDA source

Abbott Laboratories began a recall of 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... on 2012-12-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0698-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-12
Posted: 2013-01-23
Terminated: 2016-12-23
Recalling firm: Abbott Medical
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.
Product code: MRG System, Test, Vitamin D
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 root cause: Mixed-up of materials/components
Action: 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.
Quantity in commerce: 28,600 total
Distribution: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0698-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0698-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23

Product code MRG

K110619Class IIArchitect 25-Oh Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsBiokit, S.A. / cleared 2011-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)