Lower riskMedical device recall · FDA · Published July 12, 2021
Stanbio Beta-Hydroxybutyrate Reagent A Recall: Stability Issues Affect Test Results
Stanbio recalls unlabeled Beta-Hydroxybutyrate Reagent A enzyme for unstable quality control values. This in vitro diagnostic reagent may produce inaccurate test results if used improperly.
“Stanbio Beta-Hydroxybutyrate Reagent A Recall: Stability Issues Affect Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62213-stanbio-beta-hydroxybutyrate-reagent-a-recall-stability-issues-affect-test. Based on FDA recall #Z-2200-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2200-2021%22&limit=1).
The FDA announced on July 12, 2021, that Stanbio Laboratory, LP voluntarily recalled Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled) in vitro diagnostic reagent. The hazard is deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
How to tell if you have it
Brand: Stanbio
Product: Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled)
Catalog Number: 2441-050U
Lot Number: 158894
Units affected: 200
The hazard
Deterioration in the stability of the reagents has resulted in lower than expected or out of range Quality Control values.
Context
GovInfoNow's records show Stanbio Laboratory, LP has 4 other recalls on record since Feb. 8, 2018. Other recent recalls include STAT-Site M BHB Test Strips (Oct. 2, 2023), Creamatocrit Plus (March 16, 2022), and RaPET RF Latex Reagent (Feb. 13, 2018). Other recent recalls of similar products include Bioporto ProNephro AKI Reagent Kit (May 18, 2026), Siemens Atellica CH Urine Albumin (July 6, 2026), and Changchun Wancheng Bio-Electron UTI Test Strips (Nov. 22, 2025).
How to tell if you have this one
Check for the unlabeled Beta-Hydroxybutyrate Reagent A - Enzyme (product code 2441-050U) with lot number 158894. This reagent is used in in vitro diagnostic testing.
Brand
Stanbio
Category
Medical device
FDA recall event · 5 products
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
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.
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.; Catalog Number/Product Description: CH2440058/Cardinal Health ¿-Hydroxybutyrate LiquiColor Device Identifier: 10885380173127 Lot Numbers: 166355; 165053; 163944; 162092;
3,940 units
Z-2203-2021
Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.; Catalog Number/Product Description: CHB2440180/Cardinal Health ¿-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX Device Identifier: 10885380173141 Lot Numbers: 164986;
93 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify if your reagent has the product code 2441-050U and lot number 158894.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 38 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2200-2021 (July 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2200-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.