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U.S. Department of Health and Human Services

Class 2 Device Recall AxisShield Liquid Stable (LS) 2Part Homocysteine Reagent

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  Class 2 Device Recall AxisShield Liquid Stable (LS) 2Part Homocysteine Reagent see related information
Date Initiated by Firm September 16, 2019
Create Date December 26, 2019
Recall Status1 Open3, Classified
Recall Number Z-0743-2020
Recall Event ID 84043
510(K)Number K083222  
Product Classification Urinary homocystine (nonquantitative) test system - Product Code LPS
Product 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.
Code Information UDI: 05055845400169; Lot Number 902924526
Recalling Firm/
Manufacturer		 Axis-Shield Diagnostics, Ltd.
17 Luna Place
Dundee United Kingdom
Manufacturer Reason
for Recall		 There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
FDA Determined
Cause 2		 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 in Commerce 740 total
Distribution US Nationwide distribution in the states of CA, KY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LPS and Original Applicant = AXIS-SHIELD DIAGNOSTICS, LTD.
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