Device product
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.
Z-0743-2020
Product summary
- Event
- Event 84043
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 740 total
- Official record key
device-enforcement:Z-0743-2020
Official wording
Reason: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Code information: UDI: 05055845400169; Lot Number 902924526
Distribution pattern: US Nationwide distribution in the states of CA, KY.
Derived failure modes
-
Unknown
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.