FDA Medical Device Recalls (openFDA)
Axis-Shield Diagnostics, Ltd.: 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 number
- Z-0744-2020
- Recalling firm
- Axis-Shield Diagnostics, Ltd.
- Product
- 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.
- Status
- Open, Classified
- Initiated
- 2019-09-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 740 total
- Distribution
- US Nationwide distribution in the states of CA, KY.
- Lot, serial or model codes
- UDI: 05055845400183; Lot Number 902924815
- 510(k) numbers
- ["K083222"]
- PMA numbers
- not on file
- Product code
- LPS
- Firm FEI
- 3002808140
- Firm city
- Dundee
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28