CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
The HemoCue Glucose 201 Microcuvettes are designed recalled
HemoCue AB is recalling The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201, distributed nationwide in the US. The recall was initiated on 12 May 2025 and the FDA has classified it as Class II.
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-2070-2025
- FDA event ID
- 97025
- Recalling firm
- HemoCue AB, Angelholm
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 May 2025
- FDA classified
- 2 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 12 May 2025 | Recall initiated by company | |
| 2 Jul 2025 | Classified by FDA | +51 days |
| 9 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
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
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.
Where it was distributed
US Nationwide distribution in the state of AR.
Questions about this recall
Why was it recalled?
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
Which lots are affected?
UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)
Where was it sold?
US Nationwide distribution in the state of AR.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from HemoCue AB
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HemoCue¿ Hb 201 Microcuvettes recalled by HemoCue AB | HemoCue AB | Other | 38 states |
| Device | CLASS II | HemoCue¿ Urine Albumin Microcuvettes recalled by HemoCue AB | HemoCue AB | Potency & Assay | Nationwide |
| Device | CLASS II | HemoCue¿ Glucose 201 Microcuvettes recalled by HemoCue AB | HemoCue AB | Packaging Defects | Nationwide |
| Device | CLASS III | Analyzing system consists of a small recalled by HemoCue AB | HemoCue AB | Packaging Defects | 17 states |
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| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |