—#135438

Product

MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 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.

FDA product code: JWY — Manual Antimicrobial Susceptibility Test Systems
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K870074
Affected lot / code info: Catalog number: B1017-412; Siemens Material Number (SMN): 10371535.

Why it was 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.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated August 7, 2014 to affected customers by trackable method. The letter describe product, problem and actions to be taken. The customers were instructed to confirm receipt of the letter; complete the attached "Field Correction Effectiveness Check" form via fax to Siemens Healthcare Diagnostics at 302-631-8467;TSB 190 has been removed from use and archived from the Siemens Document Library, if you have a hardcopy, discard it appropriately;and follow the listed in instructions and retain and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center; Quality Systems & Compliance Director at 916-374-3031 or email: juntalan@beckman.com or your local Siemens technical support representative.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 2040 Enterprise Blvd, West Sacramento, California 95691-3427

Distribution

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.

Timeline

Recall initiated: 2014-08-08
Posted by FDA: 2015-04-27
Terminated: 2015-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135438. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.