Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
FDA Recall Z-1525-2013 · Posted 2013-06-08
Advertisement
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeLTT
Date Initiated2013-05-02
Date Terminated2013-09-17
Product Quantity683 units
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.
Firm Action
Siemens sent an Urgent Field Safety Notice dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Siemens Healthcare Diagnostics Representative for information concerning this notice.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement