CLASS III Device recall · Reported 11 Aug 2021 · FDA Enforcement Report
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled) recalled
Stanbio Laboratory is recalling Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled), distributed nationwide in the US. The recall was initiated on 12 Jul 2021 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2200-2021
- FDA event ID
- 88323
- Recalling firm
- Stanbio Laboratory, Boerne, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Jul 2021
- FDA classified
- 5 Aug 2021
- Reported
- 11 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Jul 2021 | Recall initiated by company | |
| 5 Aug 2021 | Classified by FDA | +24 days |
| 11 Aug 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Is Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled) recalled?
Yes. Stanbio Laboratory recalled Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled) on 12 Jul 2021. The recall is Class III and its status is Terminated. Recall number Z-2200-2021.
Why was it recalled?
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Which lots are affected?
Catalog Number/Product Description: 2441-050U/¿-Hydroxybutyrate Reagent A - Enzyme (unlabeled) Lot Numbers: 158894;
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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