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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97025

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 12, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
HemoCue AB

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2070-2025
Recall number
Z-2070-2025
Initiated
May 12, 2025
Classification
Class II
Status
Ongoing
Recalling firm
HemoCue AB
Quantity
4 Boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

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Inspect official wording and provenance

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.

Code information

UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)

Distribution pattern

US Nationwide distribution in the state of AR.