Recall Z-1895-2017— Richard-Allan Scientific Company
Class II · Terminated
Class II FDA medical device recall by Richard-Allan Scientific Company, initiated 2017-03-15, terminated 2017-07-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques.. Reason: Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead..
- Recalling firm
- Richard-Allan Scientific Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-15
- Terminated
- 2017-07-27
- Firm location
- Kalamazoo, MI, United States
Product description
Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques.
Reason for recall
Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.
Data sourced from openFDA. This site is unofficial and independent of the FDA.