HemoCue AB recalls

HemoCue AB has 5 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 9 Jul 2025. 1 is still ongoing. The most frequent reason is potency & assay.

Total recalls5since 2013

Last 12 months0reported

Class I00% of total

Ongoing1latest 9 Jul 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 1Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 80%Class III 1 20%

Why hemocue ab is recalled

Product types

By year

2025120%
2013480%

Ongoing hemocue ab recalls

1 active

Reported	Class	Recall	Company	Reason	Where
9 Jul 2025Device	CLASS II	The HemoCue Glucose 201 Microcuvettes are designed recalled	HemoCue AB	Potency & Assay	Nationwide

All hemocue ab recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
9 Jul 2025Device	CLASS II	The HemoCue Glucose 201 Microcuvettes are designed recalled	HemoCue AB	Potency & Assay	Nationwide
6 Nov 2013Device	CLASS II	HemoCue¿ Hb 201 Microcuvettes recalled by HemoCue AB	HemoCue AB	Other	38 states
6 Nov 2013Device	CLASS II	HemoCue¿ Urine Albumin Microcuvettes recalled by HemoCue AB	HemoCue AB	Potency & Assay	Nationwide
18 Sep 2013Device	CLASS II	HemoCue¿ Glucose 201 Microcuvettes recalled by HemoCue AB	HemoCue AB	Packaging Defects	Nationwide
9 Jan 2013Device	CLASS III	Analyzing system consists of a small recalled by HemoCue AB	HemoCue AB	Foreign Material	17 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.