Device product
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Z-2200-2021
Product summary
- Event
- Event 88323
- Status
- Terminated
- Classification
- Class III
- Quantity
- 200 units
- Official record key
device-enforcement:Z-2200-2021
Official wording
Reason: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Code information: Catalog Number/Product Description: 2441-050U/¿-Hydroxybutyrate Reagent A - Enzyme (unlabeled) Lot Numbers: 158894;
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.
Derived failure modes
-
Unknown
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.