FDA Medical Device Recalls (openFDA)
Richard-Allan Scientific Company: 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.
- Recall number
- Z-1895-2017
- Recalling firm
- Richard-Allan Scientific Company
- 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.
- Status
- Terminated
- Initiated
- 2017-03-15
- Posted
- 2017-04-17
- Terminated
- 2017-07-27
- Reason
- Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.
- Root cause
- Mixed-up of materials/components
- 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.
- Quantity
- 390
- Distribution
- 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, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HYF
- Firm FEI
- 1831638
- Firm city
- Kalamazoo
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28