Recall Z-2070-2025— HemoCue AB

Name: FDA recall Z-2070-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-12

Class II · Ongoing

Class II FDA medical device recall by HemoCue AB, initiated 2025-05-12. It names one FDA 510(k) clearance: K020935. Product: 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.. 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..

Recalling firm: HemoCue AB
Classification: Class II
Status: Ongoing
Initiated: 2025-05-12
Firm location: Angelholm, Sweden

510(k) clearances named in this recall

1 on FDA's record

K020935 — HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706Hemocue, Inc.·cleared 2002-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.