HemoCue AB Recalls
5 recalls on record · January 9, 2013 to July 9, 2025 · Medical Devices
Recalls by year
13
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 9, 2025Medical DevicesFDA
HemoCue AB recalls The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma con
Hazard: 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.
November 6, 2013Medical DevicesFDA
HemoCue AB recalls HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
Hazard: HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.
November 6, 2013Medical DevicesFDA
HemoCue AB recalls HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidim
Hazard: HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches.
September 18, 2013Medical DevicesFDA
HemoCue AB recalls HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes a
Hazard: During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
January 9, 2013Medical DevicesFDA
HemoCue AB recalls Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents
Hazard: Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.