The Recall Desk
ModerateFDA (Devices)·Z-1895-2017·Announced 2017-05-10

Richard-Allan Scientific Recalls Shandon Rapid Chrome Kwik-Diff Kits

Richard-Allan Scientific is recalling Shandon Rapid Chrome Kwik-Diff Kits because the Methylene Blue Solution #3 was mislabeled and actually contained Crystal Violet.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is a mislabeling of a reagent, which is a labeling error rather than a direct physical injury risk.

Plain-English summary

Richard-Allan Scientific Company is recalling Shandon Rapid Chrome Kwik-Diff Kits and Shandon Rapid Chrome Kwik-Diff Reagent #3. The recall involves 390 units of the product, which is intended for use in special stain techniques. The affected products include Part Number 9990700 (sold in 500ml bottles) and Part Number 9990707 (sold in 4L bottles).

The recall was initiated because the Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead. This mislabeling means the reagent does not match the product description and intended use. The affected lot numbers for Part Number 9990700 are S-645, S-646, and S-647, and for Part Number 9990707 are 234, 235, and 236. The expiration dates for these lots range from 8/18/2018 to 12/10/2018.

The products were distributed worldwide, including in the United States (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 in the countries of AE, BH, CA, CZ, FR, GB, HK, SA, and TR. Users should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

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
Affected units
390

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 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

Distribution