Recall Z-0170-2015— Siemens Healthcare Diagnostics, Inc.
Class I · Terminated
Class I FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2014-10-17, terminated 2015-06-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-10-17
- Terminated
- 2015-06-29
- Firm location
- West Sacramento, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.