Recall Z-1525-2013— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-05-02, terminated 2013-09-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.. Reason: The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-02
- Terminated
- 2013-09-17
- Firm location
- West Sacramento, CA, United States
Product description
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
Reason for recall
The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.
Data sourced from openFDA. This site is unofficial and independent of the FDA.