Recall Z-1056-2007 ยท LAO Enzyme Immunoassay, Methotrexate
Abbott Diagnostic International, Ltd.
TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent system is composed of one bottle of Wash Solution, one bottle of Methotrexate Antibody, one bottle of Methotrexate Fluorescein Tracer and one bottle of Pretreatment Solution.
| Date | Jul 20, 2007 (initiated Mar 20, 2007) |
| Status | Terminated |
| Reason | Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P. |
| Root cause | Other |
| Action | The Product Correction Letter dated 3/20/2007, was sent to all customers who received the affected lots. The Customers were instructed to: Determine if they had the lot listed in the Product Correction letter. Inspect each kit of the affected lot and discard any kits incorrectly configured. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them and retain Product Correction letter for their laboratory records. |
| Quantity | 1,026 |
| Distribution | World wide Distribution : USA including states of AR, CA, CO, CT, DE, FL,GA, ID, IL, IA, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, NJ, NY, NC,NV, OH, SC, PA, RI, TN, TX, UT, WA, WI, WV, Hawaii, Washington DC, and Puerto Rico. Countries of : Canada, Mexico, Venezuela, Columbia, Chile, Brazil, German |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932615 | TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II Abbott Laboratories, Jul 14, 1993 |