Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan Pos MIC Panel Type 34

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MicroScan Pos MIC Panel Type 34 see related information
Date Initiated by Firm December 02, 2020
Create Date December 23, 2020
Recall Status1 Terminated 3 on January 03, 2023
Recall Number Z-0720-2021
Recall Event ID 86817
510(K)Number K043545  
Product Classification Instrument for auto reader & interpretation of overnight suscept. Systems - Product Code LRG
Product MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
Code Information Catalog Number: B1017-216 UDI Code: (01)15099590657550(17)210610(11)200610(10)2021-06-10  Lot Number: 2021-06-10
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Jose Untalan
916-374-3031
Manufacturer Reason
for Recall		 Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.
FDA Determined
Cause 2		 Process control
Action During the week of 12/01/2020, the Recalling Firm is sending an "URGENT MEDICAL DEVICE RECALL" Letter via e-mail and/or mail to customers informing them that due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification. Customer are instructed to: 1. Discontinue use and discard, per their laboratory procedure/guidelines, any remaining inventory of the affected lot. 2. The laboratory should consider reviewing and confirming organism identification and antimicrobial susceptibility test results of stains yielding results suggestive of a daptomycin "non-susceptible" category. 3. They should retain their inventory of other B1017-216 panel lots as they are not impacted by this issue. 4. Share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. If they have forwarded any of the affected product to any additional laboratories, they are instructed to provide the information/notification. 5. To assure receipt of the notification/important communication, customers are instructed to respond within 10 days in one of the following ways: -Electronically, if they received the communication via email -Manually complete and return the enclosed Response Form. The Recalling Firm is investigating the root cause of the issues and appropriate actions to prevent recurrence will be implemented. For questions, contact Customer Support Center at: -websited http://www.beckmancoulter.com -Phone 1-800-677-7226 in the United States -For customers in the United States, if replacement product is needed: --Complete the attached "Replacement Order Form" and email to askbeckman@ Beckman.com or fax to 866-294-7850 --Call Client Servic
Quantity in Commerce 685 panel boxes (20 panels per box) = 13,700 panels
Distribution U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, IN, KY, MA, MI, MO, NC, NH, NY, OH, OK, PA, SC, SD, TN, TX, VA, and WI. The countries of Australia, Austria, Bahamas, Bangladesh, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, Vietnam.
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 = LRG and Original Applicant = DADE BEHRING, INC.
-
-