Z-1383-2008

Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug...

Name: Z-1383-2008 Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug...
Creator: Nanosphere, Inc.
Published: 2008-02-25
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2008-02-25 / Terminated

FDA source

Nanosphere, Inc. began a recall of Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc... on 2008-02-25. The reason FDA records is "Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1383-2008
Status: Terminated
Initiated: 2008-02-25
Posted: 2008-03-31
Terminated: 2010-05-17
Recalling firm: Luminex Corporation
Product: Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc., 4088 Commercial Ave., Northbrook, IL 60062
Product code: ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Reason for recall: Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).
FDA root cause: Other
Action: Nanosphere sent Urgent Device Recall letters dated 2/25/08 to the direct accounts on the same date, informing them of the potential for aberrant results with the use of the affected lots of cartridges. The accounts were requested to examine their stocks for the affected lots of cartridges, segregate those found and return them to Nanosphere for replacement. Any questions can be directed to Dr. Gregg Shipp at 847-400-9115.
Quantity in commerce: 624 units
Distribution: Nationwide; USA including states of Kentucky, Michigan, Tennessee, Texas, Louisiana, Connecticut, Illinois, and California.
Product codes and lots: Lot Numbers 121907002B, 010708002A, 012108002A, 012108002C, 012208002C, 012408002B, 012808002A, and 020608002A

Product code ODW

K070804Class IIVerigene System, Verigene Warfarin Metabolism Nucleic Acid TestNanosphere, Inc. / cleared 2007-09-17

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)