Z-1689-2016 Class II Terminated
FDA device recall Z-1689-2016 was initiated by Diamedix Corporation on March 26, 2015 and is designated Class II. Reason for recall: Product contained an incorrect substrate. The recall status is terminated (terminated November 14, 2018). Affected quantity: 150 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2016
- Initiation Date
- March 26, 2015
- Termination Date
- November 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 kits
Product Description
Diamedix Is-CMV IgG Test Kit
Reason for Recall
Product contained an incorrect substrate.
Distribution Pattern
AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.
Code Information
Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016