MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting C

FDA device recall Z-1534-2015 · posted 2015-04-27 · Terminated

Recall details

Recalling firm

Beckman Coulter, Inc.

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.

Action taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

JWY

Quantity affected

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 Fe

Date initiated

2014-08-08

Date posted

2015-04-27

Date terminated

2015-04-27

Location

West Sacramento, CA

Related 510(k) clearances