Z-2203-2021Class III

Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent

Name: Z-2203-2021 Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent
Creator: Stanbio Laboratory, LP
Published: 2021-07-12
License: https://open.fda.gov/license/

Stanbio Laboratory / initiated 2021-07-12 / Terminated

FDA source

Stanbio Laboratory, LP began a recall of Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent on 2021-07-12. FDA classified it as Class III and gives the reason as "Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2203-2021
Classification: Class III
Status: Terminated
Initiated: 2021-07-12
Posted: 2021-08-05
Terminated: 2022-03-29
Recalling firm: Stanbio Laboratory
Product: Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
Product code: JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Reason for recall: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
FDA root cause: Under Investigation by firm
Action: On 07/12/2021, the firm sent an "PRODUCT CORRECTION NOTIFICATION" Letter via First Class mail (U.S.) and email (O.U.S.) to inform customers that the Recalling Firm has observed deterioration in the stability of the liquid reagents which has resulted in lower than expected or out of range Quality Control values. Customers are instructed to: 1) Discontinue use of and quarantine any affected product. 2) Only the lot listed in the table provided are affected and customers may continue to use any other lots they may have in their possession. 3) Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. 4) If customers have forwarded the product to another laboratory, please provide a copy of this letter to them. Provide the name, address and a contact for the laboratory on the Verification Form. 5) Complete and FAX or email the enclosed Verification Form within 10 days to confirm their receipt of this notice. If you have further questions, please contact Technical Support at 1-800-531-5535 ext. 128.
Quantity in commerce: 93 units
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.
Product codes and lots: Catalog Number/Product Description: CHB2440180/Cardinal Health ¿-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX Device Identifier: 10885380173141 Lot Numbers: 164986;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2203-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2199-2021	Class III	Terminated	Voluntary: Firm initiated	2021-08-11	2021-08-05
Z-2200-2021	Class III	Terminated	Voluntary: Firm initiated	2021-08-11	2021-08-05
Z-2201-2021	Class III	Terminated	Voluntary: Firm initiated	2021-08-11	2021-08-05
Z-2202-2021	Class III	Terminated	Voluntary: Firm initiated	2021-08-11	2021-08-05
Z-2203-2021	Class III	Terminated	Voluntary: Firm initiated	2021-08-11	2021-08-05

Product code JIN

K910108Class IGds Enzymatic B-Hydroxybutyrate Reagent ModifiedGds Diagnostics / cleared 1991-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)