Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila
Lot Codes / Batch Numbers
Lot Number: 45050Q100
Products Sold
Lot Number: 45050Q100
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila is recalling TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic u due to Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NV, NJ, NY, NC, OH, PA, RI, SC, TN, TX, UT, WA, WV, WI, DC
Page updated: Jan 10, 2026