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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall AxisShield Liquid Stable (LS) 2Part Homocysteine Assay see related information
Date Initiated by Firm March 20, 2015
Date Posted July 01, 2015
Recall Status1 Terminated 3 on October 27, 2015
Recall Number Z-1946-2015
Recall Event ID 70992
510(K)Number K083222  
Product Classification Urinary homocystine (nonquantitative) test system - Product Code LPS
Product Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800))

Product Usage:
For in-vitro quantitative determination of total homocysteine in human plasma or serum.
Code Information Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104
Recalling Firm/
Manufacturer		 Axis-Shield Diagnostics, Ltd.
The Technology Park
Luna Place
Dundee United Kingdom
Manufacturer Reason
for Recall		 Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
FDA Determined
Cause 2		 Under Investigation by firm
Action Axis Shield sent an Urgent Field Safety Notice letter dated March 20, 2015 to their customers via email and written notice sent with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. Recommended Action to Customer is as follows: Confirm receipt of FSN to Axis-Shield. Do not use the affected Reagent lots referenced in the safety notice. In the event of holding one of the affected lots, immediately contact Axis-Shield Product Support Department to arrange for replacement material and return any defective product to Axis-Shield. Complete reconciliation form. Complete acknowledgement of the safety notice within 10 working days. Ensure safety notice has been distributed and reviewed by all appropriate personnel within your organization. If further distribution of affected lots to another organization has been made, inform them of this Product Recall and provide a copy of this safety notice to them. Retain a copy of the safety notice for their records. For any issues or concerns contact Axis-Shield via e-mail; MDL-AXD-Product- Support@alere.com.
Quantity in Commerce 52 kits + 75 kits Beckman Coulter Brand OUS
Distribution Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPS and Original Applicant = AXIS-SHIELD DIAGNOSTICS, LTD.
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