Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. 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 LiquiColor reagent for Synchron CX/LX/DX laboratory testing equipment due to deterioration in the stability of the reagents. This deterioration has caused Quality Control values to fall below expected levels or fall outside acceptable ranges. The affected product is Lot Number 164986 (Catalog Number CHB2440180), consisting of 93 units that were distributed nationwide across the United States, Puerto Rico, and internationally to Australia, Canada, Chile, Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Vietnam.
The recall record does not specify a remedy or recommended action for consumers or affected parties.
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: 93 units Lot/code info: Catalog Number/Product Description: CHB2440180/Cardinal Health ¿-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX Device Identifier: 10885380173141 Lot Numbers: 164986;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.