MicroScan Pos MIC Panel Type 34 - Product Usage: For recall
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species…
Why was MicroScan Pos MIC Panel Type 34 - Product Usage: For 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: B1017-216 UDI Code: (01)15099590657550(17)210610(11)200610(10)2021-06-10 Lot Number: 2021-06-10
- Product
- MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 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.
- Recall date
- December 30, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)