Beckman Coulter Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Catalog Number: B1017-216 UDI Code: (01)15099590657550(17)210610(11)200610(10)2021-06-10 Lot Number: 2021-06-10
Beckman Coulter Inc. is recalling MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent suscep due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026