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
This recall has been terminated (originally issued March 31, 2008).
- Company
- Nanosphere, Inc.
- Recall Initiated
- February 25, 2008
- Posted
- March 31, 2008
- Terminated
- May 17, 2010
- Recall Number
- Z-1383-2008
- Quantity
- 624 units
- Firm Location
- Northbrook, IL
- Official Source
- View on FDA website ↗
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).
Distribution
Nationwide; USA including states of Kentucky, Michigan, Tennessee, Texas, Louisiana, Connecticut, Illinois, and California.
Lot / Code Info
Lot Numbers 121907002B, 010708002A, 012108002A, 012108002C, 012208002C, 012408002B, 012808002A, and 020608002A
Root Cause
Other
Action Taken
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.