Z-2199-2021 Class III Terminated
FDA device recall Z-2199-2021 was initiated by Stanbio Laboratory, LP on July 12, 2021 and is designated Class III. Reason for recall: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. The recall status is terminated (terminated March 29, 2022). Affected quantity: 7,108 products.
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
- 7,108 products
Product Description
Reason for Recall
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.