The HemoCue Glucose 201 Microcuvettes are designed for use… recallZ-2070-2025 · HemoCue AB · initiated May 12, 2025
Open, Classified
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 HemoCue AB 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
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.
FDA root cause category: Storage
What the company is doing
On 5/14/2025 field notices were emailed to customers who were asked to do the following: 1) Ensure that the affected product at customer site has been destroyed according to local regulations. 2) Complete and return the Field Notice Verification Form. If you have any questions regarding this Field Notice, please send an e-mail to [email protected]
Recall details
- Recall number
- Z-2070-2025
- Status
- Open, Classified
- Initiated by the company
- May 12, 2025
- Posted by the FDA
- Jul 2, 2025
- Recalling firm
- HemoCue AB
- Quantity
- 4 Boxes
- Product code
- CGA
- FDA submissions
- K020935
- Distribution
- US Nationwide distribution in the state of AR.
Product description
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.
Code information (models, lots, serial numbers)
UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HemoCue® Glucose 201 Microcuvettes 110706Hemocue AB · Glucose Oxidase, Glucose2 recalls0 reports
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.
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