Recall Z-0742-2020— Axis-Shield Diagnostics, Ltd.
Class II · Ongoing
Class II FDA medical device recall by Axis-Shield Diagnostics, Ltd., initiated 2019-09-16. It names one FDA 510(k) clearance: K083222. Product: 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.. Reason: There is a potential performance issue as detected by an under-recovery of sample results during routine testing..
- Recalling firm
- Axis-Shield Diagnostics, Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-09-16
- Firm location
- Dundee, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.