Recall Z-1530-2015 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Beckman Coulter, Inc.
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 susceptibili
| Date | Apr 27, 2015 (initiated Aug 8, 2014) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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 Emirate |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K870074 | GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS Microscan Div. Baxter Healthcare Corp., Apr 14, 1987 |