Z-1056-2007

TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This...

Name: Z-1056-2007 TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This...
Creator: Abbott Diagnostic International, Ltd.
Published: 2007-03-20
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2007-03-20 / Terminated

FDA source

Abbott Diagnostic International, Ltd. began a recall of 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... on 2007-03-20. The reason FDA records is "Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1056-2007
Status: Terminated
Initiated: 2007-03-20
Posted: 2007-07-20
Terminated: 2011-06-10
Recalling firm: Abbott Diagnostic International, Ltd.
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.
Product code: LAO Enzyme Immunoassay, Methotrexate
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.
FDA 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 in commerce: 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, Germany, Japan, Hong Kong, Australia and New Zealand
Product codes and lots: Lot Number: 45050Q100

Product code LAO

K932615UnclassifiedTdx(r)/tdx(r)flx(r)mehtotrexate IIAbbott Laboratories / cleared 1993-07-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)