Class 2 Device Recall Sekure Chemistry Acetaminophen L3K

• Date Initiated by Firm: July 20, 2017
• Create Date: September 12, 2017
• Recall Status: Terminated 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: 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