Recalls / —
—#118168
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.
- FDA product code
- LTT — Panels, Test, Susceptibility, Antimicrobial
- Device class
- Class 2
- Medical specialty
- Microbiology
- Affected lot / code info
- Lot: 2013-11-13, Exp 11/13/2013.
Why it was recalled
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.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 2040 Enterprise Blvd, West Sacramento, California 95691-3427
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2013-05-02
- Posted by FDA
- 2013-06-08
- Terminated
- 2013-09-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #118168. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.