Recall Z-2070-2025 ยท CGA Glucose Oxidase, Glucose
HemoCue AB
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.
| Date | Jul 2, 2025 (initiated May 12, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Storage |
| 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 cuvettes@hemocue.com |
| Quantity | 4 Boxes |
| Distribution | US Nationwide distribution in the state of AR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020935 | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 Hemocue, Inc., Apr 3, 2002 |