Device product
Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.
Z-1264-2015
Product summary
- Event
- Event 70562
- Status
- Terminated
- Classification
- Class III
- Quantity
- 132
- Official record key
device-enforcement:Z-1264-2015
Official wording
Reason: The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain.
Code information: Lot: 313833 Expiration date: 11/2016
Distribution pattern: US, Canada and Europe
Derived failure modes
-
Labeling or packaging
incorrectly labeled