Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic… recallZ-2199-2021 · Stanbio Laboratory, LP · initiated Jul 12, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stanbio Laboratory, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2199-2021
- Status
- Terminated
- Initiated by the company
- Jul 12, 2021
- Recalling firm
- Stanbio Laboratory, LP
- Quantity
- 7,108 products
- Product code
- JIN
- FDA submissions
- K910108
- 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 description
Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
Code information (models, lots, serial numbers)
Catalog Number/Product Description: 2440-058/¿-Hydroxybutyrate LiquiColor Device Identifier: 00657498000519 Lot Numbers: 164312; 161081; 161039; 161031; 158972;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- B-Hydroxybutyrate LiquiColor® 2440-058Stanbio Laboratory, L.P. · Nitroprusside, Ketones (Urinary, Non-Quant.)2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 88323).
- Z-2201-2021 · TerminatedSynchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
- Z-2202-2021 · TerminatedCardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
- Z-2203-2021 · TerminatedCardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page