CLASS III Device recall · Reported 11 Aug 2021 · FDA Enforcement Report
Cardinal Health Beta-Hydroxybutyrate LiquiColor recalled
Stanbio Laboratory is recalling Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro, 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-2203-2021
- 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
Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. 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
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: CHB2440180/Cardinal Health ¿-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX Device Identifier: 10885380173141 Lot Numbers: 164986;
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 88323This product is part of a recall event; the main page for the event is Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled) recalled | Stanbio Laboratory | Potency & Assay | Nationwide | |
| CLASS III | Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent recalled | Stanbio Laboratory | Potency & Assay | Nationwide | |
| CLASS III | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent recalled | Stanbio Laboratory | Potency & Assay | Nationwide | |
| CLASS III | Beta-Hydroxybutyrate LiquiColor recalled by Stanbio Laboratory | Stanbio Laboratory | Potency & Assay | Nationwide |
More recalls from Stanbio Laboratory
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stat-Site M Bhb Test Strips, used recalled by Stanbio Laboratory | Stanbio Laboratory | Potency & Assay | Nationwide |
| Device | CLASS II | Separation Technology Creamatocrit Plus recalled by Stanbio Laboratory | Stanbio Laboratory | Other | Nationwide |
| Device | CLASS III | Beta-Hydroxybutyrate LiquiColor recalled by Stanbio Laboratory | Stanbio Laboratory | Potency & Assay | Nationwide |
| Device | CLASS III | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent recalled | Stanbio Laboratory | Potency & Assay | Nationwide |
| Device | CLASS III | Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent recalled | Stanbio Laboratory | Potency & Assay | Nationwide |
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| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |