Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #...

FDA Device Recall #Z-1895-2017 — Class II — March 15, 2017

Recall Summary

Recall Number Z-1895-2017
Classification Class II — Moderate risk
Date Initiated March 15, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Richard-Allan Scientific Company
Location Kalamazoo, MI
Product Type Devices
Quantity 390

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.

Distribution Pattern

Worldwide Distribution -- US: CA, CO, CT, DE, GA, HI, IA, IL, KS, MA, MS, NC, NH, NM, NY, OH, PA, PR, RI, UT, VA, VT, WA, and WV; and, the countries of AE, BH, CA, CZ, FR, GB, HK, SA, and TR.

Lot / Code Information

Part Number: 9990700 Lot Number S-645, S-646 and S-647 Part Number 9990707 Lot: 234, 235, and 236 Expiration date: 8/18/2018-12/10/2018

Other Recalls from Richard-Allan Scientific Company

Recall # Classification Product Date
Z-2749-2018 Class III EZ Single Cytofunnel Brown, A78710004 Produc... Jun 4, 2018
Z-2351-2016 Class II Richard Allan Scientific 10% Neutral Buffered F... Jun 13, 2016
Z-1319-2016 Class III Richard-Allan Scientific Paraffin Type 3 For i... Feb 16, 2016
Z-1640-2015 Class II Lerner Laboratories Mucolexx, 1 pint / 473 ml &... Apr 29, 2015
Z-1639-2015 Class II Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l ... Apr 29, 2015

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.