Z-2070-2025Class II

The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with...

Name: Z-2070-2025 The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with...
Creator: HemoCue AB
Published: 2025-05-12
License: https://open.fda.gov/license/

HemoCue AB / initiated 2025-05-12 / Open, Classified / root cause: labeling and UDI

FDA source

HemoCue AB began a recall of The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured... on 2025-05-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2070-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-12
Posted: 2025-07-02
Recalling firm: HemoCue AB
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.
Product code: CGA Glucose Oxidase, Glucose
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.
Root cause tag: labeling and UDI
FDA 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 [email protected]
Quantity in commerce: 4 Boxes
Distribution: US Nationwide distribution in the state of AR.
Product codes and lots: UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2070-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2070-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-02

Product code CGA

K020935Class IIHemocue Glucose 201 System, Article Number 120706Hemocue, Inc. / cleared 2002-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)