Recall Z-1264-2015— Richard-Allan Scientific Company
Class III · Terminated
Class III FDA medical device recall by Richard-Allan Scientific Company, initiated 2015-02-19, terminated 2016-01-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Richard-Allan Scientific Company
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-02-19
- Terminated
- 2016-01-12
- Firm location
- Kalamazoo, MI, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.