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Axis-Shield Diagnostics Recalls
4 recalls on record · July 8, 2015 to January 1, 2020 · Medical Devices
Recalls by year
15
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 1, 2020Medical DevicesFDA
Axis-Shield Diagnostics, Ltd. recalls Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist
Hazard: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
January 1, 2020Medical DevicesFDA
Axis-Shield Diagnostics, Ltd. recalls Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist
Hazard: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
January 1, 2020Medical DevicesFDA
Axis-Shield Diagnostics, Ltd. recalls Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist i
Hazard: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
July 8, 2015Medical DevicesFDA
Axis-Shield Diagnostics, Ltd. recalls Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and
Hazard: Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.