Device product
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Z-2146-2016
Product summary
- Event
- Event 74356
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-2146-2016
Official wording
Reason: Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
Code information: All units manufactured between October 2014 and May 2016.
Distribution pattern: U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
Derived failure modes
-
Unknown
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.