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U.S. Department of Health and Human Services

Class 2 Device Recall BECKMAN COULTER MicroScan MICroSTREP Plus Panel,MicroScan MuellerHinton Broth with 3 lysed horse b

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  Class 2 Device Recall BECKMAN COULTER MicroScan MICroSTREP Plus Panel,MicroScan MuellerHinton Broth with 3 lysed horse b see related information
Date Initiated by Firm March 26, 2018
Date Posted October 02, 2018
Recall Status1 Terminated 3 on December 19, 2018
Recall Number Z-1804-2018
Recall Event ID 79800
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
Product BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015

MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
Code Information Lot Number 1005986140, Expiration date April 1, 2018
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact
469-961-4941
Manufacturer Reason
for Recall		 Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC) for antimicrobial agents Cefaclor (Ctr) and Penicillin (P) with control organism Streptococcus pneumoniae (ATCC 49619) during quality control (QC) testing on MICroSTREP plus(R) Panel Type 1 hydrated with Mueller-Hinton Broth with 3% lysed horse blood part number B1015-25 lot number 1005986140.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Beckman Coulter sent an Urgent Medical Device Recall letter dated March 16, 2018. Please discontinue use and discard any remaining inventory of the broth lot listed above. You should retain your inventory of other lot numbers of this broth as they are not impacted by this issue. Follow the guidance in the Broth Preparation section of the panel procedural and QC manual. Beckman Coulter recommends discussing the content of this letter with your medical director regarding the need to review previous test results, conduct patient follow-up, and/or repeat testing by another lot of this broth if the isolates are still available. For further questions, please call (469) 961-4941.
Quantity in Commerce 523 boxes
Distribution Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Kuwait, South Korea and Saudi Arabia.
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.
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