Date Initiated by Firm | September 16, 2019 |
Create Date | December 26, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0742-2020 |
Recall Event ID |
84043 |
510(K)Number | K083222 |
Product Classification |
Urinary homocystine (nonquantitative) test system - Product Code LPS
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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. |
Code Information |
UDI: 05055845400282; Lot Numbers 902924530, 902925703 |
Recalling Firm/ Manufacturer |
Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LPS
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