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.
Recall
- Recall Number
- Z-0744-2020
- Event Number
- 84043
- Firm
- Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom
- FEI Number
- 3002808140
- Product Code
- LPS
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- September 16, 2019
Description
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.
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
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.
US Nationwide distribution in the states of CA, KY.
740 total