Beckman Coulter, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1530-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Product Classification:

Class II

Date Initiated: August 8, 2014

Date Posted: May 6, 2015

Recall Number: Z-1530-2015

Event ID: 70893

Reason for Recall:

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.

Status: Terminated

Product Quantity: Approx ~(216240 boxes U.S. and 84249 boxes OUS) total

Code Information:

Catalog number: B1017-407; Siemens Material Number (SMN): 110444701.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated