AB SCIEX QTRAP 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 50312
FDA device recall Z-2529-2016 · posted 2016-08-12 · Terminated
Recall details
- Recalling firm
- Ab Sciex
- Reason for recall
- MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
- Action taken
- AB SCIEX issued recall notification by letter dated June 16, 2016, to all affected customers. The letter identified the problem, provided temporary measures until a permanent software is available. A response form was to be completed and returned. questions regarding this notice contact SCI EX at +1 289 982 2712.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DOP
- Quantity affected
- 28 units
- Distribution
- Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
- Date initiated
- 2016-06-16
- Date posted
- 2016-08-12
- Date terminated
- 2017-03-02
- Location
- Framingham, MA
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