Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Check against the official notice below — it lists the full affected range.
Stanbio Laboratory, LP has recalled 100 units of its Synchron CX/DX/LX Beta-Hydroxybutyrate in vitro diagnostic reagent (Catalog Number B2440-180, Lot Number 161020) due to deterioration in reagent stability. This deterioration has caused the reagents to produce lower than expected or out of range Quality Control values. The affected product was distributed worldwide and throughout the United States, as well as to Australia, Canada, Chile, Germany, Hong Kong, Singapore, Taiwan, Thailand, the United Kingdom, and Vietnam.
The recall record does not specify a remedy or recommended action for affected consumers.
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: 100 units Lot/code info: Catalog Number/Product Description: B2440-180/Synchron CX/DX/LX ¿-Hydroxybutyrate LiquiColor Device Identifier: 00657498000526 Lot Numbers: 161020;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.