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.
Reported: November 19, 2014 Initiated: October 17, 2014 #Z-0170-2015
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1381
- Distribution
- 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.
- Location
- West Sacramento, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1381.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2014. Severity: Critical. Recall number: Z-0170-2015.
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