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Axis-Shield Diagnostics

4 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices, Diagnostic Equipment

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

Class I - Dangerous

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

Sep 16, 2019 Other Medical Devices Nationwide View Details →

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

Class I - Dangerous

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

Sep 16, 2019 Other Medical Devices Nationwide View Details →

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

Class I - Dangerous

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

Sep 16, 2019 Other Medical Devices Nationwide View Details →

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

Class I - Dangerous

Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.

Mar 20, 2015 Diagnostic Equipment Nationwide View Details →