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Recall Observatory FDA recall evidence

Device 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.

Z-1895-2017

March 15, 2017

Class II

Product summary

Firm
Richard-Allan Scientific Company
Event
Event 77011
Status
Terminated
Classification
Class II
Quantity
390
Official record key
device-enforcement:Z-1895-2017

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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