Recall Z-0698-2013 ยท MRG System, Test, Vitamin D
Abbott Laboratories
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.
| Date | Jan 23, 2013 (initiated Dec 12, 2012) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110619 | ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS Biokit, S.A., Nov 23, 2011 |