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.
FDA Recall Z-0743-2020 · Posted None
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Recalling FirmAxis-Shield Diagnostics, Ltd.
Recall StatusOpen, Classified
Product CodeLPS
Date Initiated2019-09-16
Product Quantity740 total
Reason for Recall
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of CA, KY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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