| Class 2 Device Recall Microscan Neg MIC 38, B1017412 | |
Date Initiated by Firm | August 08, 2014 |
Date Posted | April 27, 2015 |
Recall Status1 |
Terminated 3 on April 27, 2015 |
Recall Number | Z-1533-2015 |
Recall Event ID |
70893 |
510(K)Number | K870074 |
Product Classification |
Manual antimicrobial susceptibility test systems - Product Code JWY
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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. |
Code Information |
Catalog number: B1017-412; Siemens Material Number (SMN): 10371535. |
Recalling Firm/ Manufacturer |
Beckman Coulter, Inc. 2040 Enterprise Blvd West Sacramento CA 95691-3427
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For Additional Information Contact | Jose 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 |
Action | 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. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JWY
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