RegWardenFDA facility compliance records
Facility

HEMOCUE AB

5 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 1 recalls; 2013: 3 recalls; 2018: 1 inspections; 2025: 1 recalls1’123’13’14’15’16’171’18’19’20’21’22’23’241’25’26
  • Recalls (5)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2025-05-12
    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, qua…
  • Class IITerminated2013-07-25
    HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.
  • Class IITerminated2013-07-16
    HemoCue AB has become aware of a production related problem involving punctured HemoCue® Urine Albumin Microcuvettes single pack pouches.
  • Class IITerminated2013-07-15
    During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
  • Class IIITerminated2012-11-07
    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.

FDA inspections (1)

  • VAI2018-05-31
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HEMOCUE AB (FEI 3003044483) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003044483-hemocue-ab/

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