CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report

Shandon Rapid Chrome Kwik-Diff Kit recalled by Richard-Allan Scientific

Richard-Allan Scientific is recalling Shandon Rapid Chrome Kwik-Diff Kit, distributed in 24 states. The recall was initiated on 15 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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

Quantity recalled390

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1895-2017
FDA event ID: 77011
Recalling firm: Richard-Allan Scientific, Kalamazoo, MI
Classification: Class II
Status: Terminated
Recall initiated: 15 Mar 2017
FDA classified: 28 Apr 2017
Reported: 10 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

15 Mar 2017	Recall initiated by company
28 Apr 2017	Classified by FDA	+44 days
10 May 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.

Product as listed by the FDA

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.

Where it was distributed

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.

California Colorado Connecticut Delaware Georgia Hawaii Iowa Illinois Kansas Massachusetts Mississippi North Carolina New Hampshire New Mexico New York Ohio Pennsylvania Puerto Rico Rhode Island Utah

Questions about this recall

Is Shandon Rapid Chrome Kwik-Diff Kit recalled?

Yes. Richard-Allan Scientific recalled Shandon Rapid Chrome Kwik-Diff Kit on 15 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1895-2017.

Why was it recalled?

Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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