MicroScan Microbiology Systems: Dried Gram Negative recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints…
Why was MicroScan Microbiology Systems: Dried Gram Negative recalled?
Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
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: B1017-414; Siemens Material Number (SMN): 10483097.
- Product
- MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints…
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- Approx ~(216240 boxes U.S. and 84249 boxes OUS) total
- Distribution
- Worldwide Distribution: US (Nationwide) and to countries of: Argentina, Bahamas, Brazil, Canada, China, Ecuador, Egypt, Germany, Lithuania, Mexico, Paraguay, Peru Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Uruguay, and Venezuela.
- Recall date
- May 6, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)