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U.S. Department of Health and Human Services

Class 2 Device Recall Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K Assay

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  Class 2 Device Recall Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K Assay see related information
Date Initiated by Firm January 22, 2016
Create Date March 14, 2016
Recall Status1 Terminated 3 on August 09, 2016
Recall Number Z-1171-2016
Recall Event ID 73129
510(K)Number K081938  
Product Classification Colorimetry, acetaminophen - Product Code LDP
Product Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic
Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml
Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml

In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
Code Information Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294
Recalling Firm/
Manufacturer		 Sekisui Diagnostics P.E.I. Inc.
70 Watts Ave
Charlottetown Canada
For Additional Information Contact Penny White
902-628-0934
Manufacturer Reason
for Recall		 Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
FDA Determined
Cause 2		 Device Design
Action Sekisui sent an Important Field Correction - Customer Notification letter dated January 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Discard all reagent in house with a current expiration date of 2016-09. 2. Update the expiration on all remaining kits on hand with the new expiration dates provided 3. When adding additional reagent to the analyzer, a new reagent wedge should be used. 4. If crystals are observed within reagent stored on-board, reagent should be discarded and replaced with fresh reagent. 5. Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will indicate receipt of this Field Correction, act as confirm action of compliance with the actions,and allow for issuance of replacement material for expired product on hand (lots 47677, 47694, 47695). Questions contact Technical Services at 1-800-565-0265 or via email at PEIDiagnosticTechnical@sekisui-dx.com
Quantity in Commerce 14,407 kits.
Distribution Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.
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 = LDP and Original Applicant = GENZYME DIAGNOSTICS P.E.I. INC.
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