Device product
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Z-0170-2015
Product summary
- Event
- Event 69540
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1381
- Official record key
device-enforcement:Z-0170-2015
Official wording
Reason: An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
Code information: Catalog number: B1017-117, Siemens Material number 1044632, lot numbers: 2014-12-10, Exp. 2014-12-10; 2015-02-27, Exp 2015-02-27; 2015-06-23, Exp 2015-06-23.
Distribution pattern: Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.
Derived failure modes
-
Unknown
An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.