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.
FDA Recall Z-2070-2025 · Posted 2025-07-02
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Recalling FirmHemoCue AB
Recall StatusOpen, Classified
Product CodeCGA
Date Initiated2025-05-12
Product Quantity4 Boxes
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.
Firm Action
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]
Root Cause
Storage
Distribution Pattern
US Nationwide distribution in the state of AR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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