Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom
Lot Codes / Batch Numbers
UDI: 05055845400282, Lot Numbers 902924530, 902925703
Products Sold
UDI: 05055845400282; Lot Numbers 902924530, 902925703
Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom is recalling Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The due to There is a potential performance issue as detected by an under-recovery of sample results during routine testing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026