Z-2201-2021 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 11, 2021
- Initiation Date
- July 12, 2021
- Termination Date
- March 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product Description
Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Reason for Recall
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.
Code Information
Catalog Number/Product Description: B2440-180/Synchron CX/DX/LX ¿-Hydroxybutyrate LiquiColor Device Identifier: 00657498000526 Lot Numbers: 161020;