Device product
Diamedix Is-CMV IgG Test Kit
Z-1689-2016
Product summary
- Event
- Event 73194
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 kits
- Official record key
device-enforcement:Z-1689-2016
Official wording
Reason: Product contained an incorrect substrate.
Code information: Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016
Distribution pattern: AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.
Derived failure modes
-
Unknown
Product contained an incorrect substrate.