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Recall Observatory FDA recall evidence

Device 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.

Z-1525-2013

May 02, 2013

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 65188
Status
Terminated
Classification
Class II
Quantity
683 units
Official record key
device-enforcement:Z-1525-2013

Official wording

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.

Code information: Lot: 2013-11-13, Exp 11/13/2013.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.