Stanbio Beta-Hydroxybutyrate LiquiColor Reagent Recall: Stability Issues

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Recalling firmStanbio Laboratory, LP1261 N Main St · Boerne, TX 78006-3014

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Stanbio is recalling Beta-Hydroxybutyrate LiquiColor diagnostic reagents because they may become unstable, leading to inaccurate test results. This affects specific lots of the product that were sold to labs and clinics. Users should check their lot numbers to see if they are affected.

Why it’s dangerous

The reagents may deteriorate over time, causing test results to be outside expected quality control ranges. This could lead to inaccurate diagnostic findings if used in laboratory testing without proper quality checks.

Who’s affected

Lab users and clinics that purchased the affected lots of Beta-Hydroxybutyrate LiquiColor reagents. The risk is low as the issue relates to test accuracy rather than immediate safety hazards.

How to tell if you have this one

Check the lot number on the reagent packaging. Affected lots include 164312, 161081, 161039, 161031, and 158972. The product is sold as an in vitro diagnostic reagent for laboratory use.

Brand
Stanbio
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for the lot number on the reagent packaging to determine if it is one of the affected lots: 164312, 161081, 161039, 161031, or 158972.

✎ GovInfoNow

Questions people ask

What is the problem with the reagents?

The reagents may deteriorate over time, causing test results to be outside expected quality control ranges.

Which lots are affected?

Affected lots are 164312, 161081, 161039, 161031, and 158972.

Do I need to stop using the reagents?

No action is required if your lot number is not listed. If your lot number is affected, check with your lab supplier for guidance.

Take action

Contact Stanbio

We’ve drafted a message you can send Stanbio to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2199-2021 — Stanbio Stanbio

Hello,

I own a Stanbio that is covered by recall Z-2199-2021 from Stanbio.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

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-2199-2021 (July 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2199-2021 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.

Stanbio Laboratory, LP recalls Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.

Lower-risk recall