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.
- Recall Initiated
- September 16, 2019
- Recall Number
- Z-0743-2020
- Quantity
- 740 total
Reason for Recall
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Distribution
US Nationwide distribution in the states of CA, KY.
Lot / Code Info
UDI: 05055845400169; Lot Number 902924526
Root Cause
Under Investigation by firm
Action Taken
Urgent Medical Device Correction notification letters dated 9/16/19 were sent to customers. Necessary Actions Immediately discontinue use of the affected lots listed and switch to the alternate material lot(s) you may have available in your laboratory. Immediately destroy any remaining inventory of the affected lots listed according to your laboratory procedures. Complete and return the accompanying verification form Immediately order replacement material(s) if you do not have unaffected material available. Please retain this letter for your laboratory records.