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MicroScan recallZ-0720-2021 · Beckman Coulter Inc. · initiated Dec 2, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process control

What the company is doing

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

Recall details

Recall number
Z-0720-2021
Status
Terminated
Initiated by the company
Dec 2, 2020
Recalling firm
Beckman Coulter Inc.
Quantity
685 panel boxes (20 panels per box) = 13,700 panels
Product code
LRG
FDA submissions
K043545
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.

Product description

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 (models, lots, serial numbers)

Catalog Number: B1017-216 UDI Code: (01)15099590657550(17)210610(11)200610(10)2021-06-10  Lot Number: 2021-06-10

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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