Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining
FDA device recall Z-1525-2013 · posted 2013-06-08 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LTT
- Quantity affected
- 683 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-05-02
- Date posted
- 2013-06-08
- Date terminated
- 2013-09-17
- Location
- West Sacramento, CA
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