The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma con
Summary
The FDA issued a Class II for The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Gluc by HemoCue AB. Reason: Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. Th.
Details
Source
Device Recall
External ID
Z-2070-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)
Quantity Affected: 4 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.
Distribution
US Nationwide distribution in the state of AR.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-12
Company
Angelholm
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (HemoCue AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HemoCue AB have FDA actions?
This is the only FDA action we have on record for HemoCue AB in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2070-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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