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Terminated

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.

FDA Recall Z-1895-2017 · Posted 2017-04-17

Recall StatusTerminated
Product CodeHYF
Date Initiated2017-03-15
Date Terminated2017-07-27
Product Quantity390

Reason for Recall

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

Firm Action

On 3/15/2017, URGENT MEDICAL DEVICE RECALL letters were sent to the affected consignees. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER Please contact Richard Allan Scientific for directions on safe disposal or return if customers have affected lots. All other lots of the products, or similar products manufactured by Richard Allan Scientific, are unaffected. Upon identification of the affected lot, please notify Richard Allan Scientific of the quantity and the preferred disposal/return method. If product is being disposed of, evidence of disposal is required to be sent to Richard Allan Scientific. If affected product has been used with no issues, please notify Richard Allan Scientific of the quantity that is unavailable for return or disposal. Please use the attached Recall Return Response Acknowledgement & Receipt Form.

Root Cause

Mixed-up of materials/components

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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