Stanbio Laboratory, LP: Medical Device Recall in 2021 - (Recall #: Z-2202-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.

Product Classification:

Class III

Date Initiated: July 12, 2021

Date Posted: August 11, 2021

Recall Number: Z-2202-2021

Event ID: 88323

Reason for Recall:

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Status: Terminated

Product Quantity: 3,940 units

Code Information:

Catalog Number/Product Description: CH2440058/Cardinal Health ¿-Hydroxybutyrate LiquiColor Device Identifier: 10885380173127 Lot Numbers: 166355; 165053; 163944; 162092;

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.

Voluntary or Mandated:

Voluntary: Firm initiated