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U.S. Department of Health and Human Services

Class 2 Device Recall Shandon Rapid Chrome KwikDiff

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  Class 2 Device Recall Shandon Rapid Chrome KwikDiff see related information
Date Initiated by Firm March 15, 2017
Date Posted April 17, 2017
Recall Status1 Terminated 3 on July 27, 2017
Recall Number Z-1895-2017
Recall Event ID 77011
Product Classification Giemsa stain - Product Code HYF
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.

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 
Recalling Firm/
Manufacturer		 Richard-Allan Scientific Company
4481 Campus Dr
Kalamazoo MI 49008-2590
For Additional Information Contact Michelle Bowennan
269-544-5625
Manufacturer Reason
for Recall		 Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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