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U.S. Department of Health and Human Services

Class 2 Device Recall Microscan Neg Breakpoint Combo 47, B1017417

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 Class 2 Device Recall Microscan Neg Breakpoint Combo 47, B1017417see related information
Date Initiated by FirmAugust 08, 2014
Date PostedApril 27, 2015
Recall Status1 Terminated 3 on April 27, 2015
Recall NumberZ-1529-2015
Recall Event ID 70893
510(K)NumberK870074 
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
ProductMicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 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.
Code Information Catalog number: B1017-417; Siemens Material Number (SMN): 10483099.
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information ContactJose Untalan
916-374-3031
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionThe 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.
Quantity in CommerceApprox ~(216240 boxes U.S. and 84249 boxes OUS) total
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWY
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