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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Synchron Systems Opiate 300 Ng (OP) Rreagent see related information
Date Initiated by Firm September 04, 2019
Create Date April 20, 2020
Recall Status1 Completed
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 2
Under Investigation by firm
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.
510(K) Database 510(K)s with Product Code = DJG and Original Applicant = BECKMAN COULTER, INC.
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