The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma con
FDA device recall Z-2070-2025 · posted 2025-07-02 · Open, Classified
Recall details
- Recalling firm
- HemoCue AB
- 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.
- Action taken
- 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 cuvettes@hemocue.com
- Root cause
- Storage
- Status
- Open, Classified
- Product code
- CGA
- Quantity affected
- 4 Boxes
- Distribution
- US Nationwide distribution in the state of AR.
- Date initiated
- 2025-05-12
- Date posted
- 2025-07-02
- Location
- Angelholm, Sweden
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 (K020935) | Hemocue, Inc. | 2002-04-03 |