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.
FDA Recall Z-1056-2007 · Posted 2007-07-20
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Recalling FirmAbbott Diagnostic International, Ltd.
Recall StatusTerminated
Product CodeLAO
Date Initiated2007-03-20
Date Terminated2011-06-10
Product Quantity1,026
Reason for Recall
Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.
Firm 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.
Root Cause
Other
Distribution Pattern
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, Germany, Japan, Hong Kong, Australia and New Zealand
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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