Class 2 Device Recall Synchron Systems Opiate 300 Ng (OP) Rreagent

• Date Initiated by Firm: September 04, 2019
• Date Posted: April 20, 2020
• Recall Status: Terminated on April 28, 2021
• Recall Number: Z-1752-2020
• Recall Event ID: 85289
• 510(K)Number: K031002
• Product Classification: Enzyme immunoassay, opiates - Product Code DJG
• Product: Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.
• Code Information: Catalog Number 475024; UDI:15099590222970 ; Lot Numbers: M904130 and older including M802097, M803045, M804024, M805123, M806080, M808069, M809218, M810293, M901044, M902086, and M903175. .
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: David Davis; 305-380-2604
• Manufacturer Reason for Recall: Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.
• FDA Determined Cause: Material/Component Contamination
• Action: An Urgent Medical Device Recall Letter was sent to customers via either U.S. postal service or email beginning on 9-4-2019. The letter informs customers that studies indicate that cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP) and Opiate 2000 ng (OP2) Instructions For Use (IFU). This letter included the Instructions for Use (IFU) claims versus study results for each product. Customers were informed of which compounds (at specific concentrations or ranges) may result in false positive or false negative test results. The letter indicated that Laboratories should be aware of these findings but that retrospective review of results is not required. Customers were informed that resolution of this issue was handled by revising the Opiate 300 ng (OP) Reagent IFU and the Opiate 2000 ng (OP2) Reagent IFU to update the Cross Reactivity sections. Customers were also requested to provide a copy of the letter to any other laboratory to which they may have forwarded affected product. Customers were requested to acknowledge receipt of the recall notification letter by responding to Beckman Coulter within 10 days either electronically, if the letter was received via email, or manually by completing and return the enclosed Response Form. Customers were instructed to contact the Beckman Coulter Customer Support Center through their website at http://www.beckmancoulter.com/customersupport/support; or by phone at 1-800-854-3633 in the United States and Canada with any questions. Customers outside of the U.S. and Canada were instructed to contact their local Beckman Coulter Representative.
• Quantity in Commerce: 7,951 units
• Distribution: Distributed throughout the United States and to Puerto Rico. States include: CA, NC, OR, MI, GE, AL, SC, TX, NJ, IA, MS, IN, MA, NC, OH, AZ, LA, MA, NY, PA, KY, WV, MI, WA, CO, IL, VA, FL, KS, MD, ID, DE, NV, OK, AR, HI, WI, NY.
• 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 = DJG and Original Applicant = BECKMAN COULTER, INC.