Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Check against the official notice below — it lists the full affected range.
Stanbio Laboratory, LP is recalling Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagent kits due to deterioration in the stability of the reagents, which has caused quality control values to be lower than expected or out of range. The recall affects 3,940 units distributed nationwide across the United States and internationally to Australia, Canada, Chile, Germany, Hong Kong, Singapore, Taiwan, Thailand, the United Kingdom, and Vietnam. The affected products are identified by Catalog Number CH2440058 and Lot Numbers 166355, 165053, 163944, and 162092.
The source document does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
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: 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. Quantity: 3,940 units Lot/code info: Catalog Number/Product Description: CH2440058/Cardinal Health ¿-Hydroxybutyrate LiquiColor Device Identifier: 10885380173127 Lot Numbers: 166355; 165053; 163944; 162092;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.