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U.S. Department of Health and Human Services

Class 2 Device Recall Sekure Chemistry Acetaminophen L3K

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  Class 2 Device Recall Sekure Chemistry Acetaminophen L3K see related information
Date Initiated by Firm July 20, 2017
Create Date September 12, 2017
Recall Status1 Terminated 3 on January 04, 2018
Recall Number Z-3118-2017
Recall Event ID 77896
510(K)Number K081938  
Product Classification Colorimetry, acetaminophen - Product Code LDP
Product Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
Code Information All lots
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Geraldine Fuentespina
714-961-3777
Manufacturer Reason
for Recall		 Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued letters dated 7/17/2017 via regular mail and email on 7/20/2017 to all customers receiving the affected product.
Quantity in Commerce 320 units
Distribution Distribution US nationwide.
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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