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U.S. Department of Health and Human Services

Class 3 Device Recall CYTOSTAIN

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  Class 3 Device Recall CYTOSTAIN see related information
Date Initiated by Firm February 19, 2015
Date Posted March 11, 2015
Recall Status1 Terminated 3 on January 12, 2016
Recall Number Z-1264-2015
Recall Event ID 70562
Product Classification Stain, papanicolau - Product Code HZJ
Product Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.
Code Information Lot: 313833 Expiration date: 11/2016
Recalling Firm/
Manufacturer		 Richard-Allan Scientific Company
4481 Campus Dr
Kalamazoo MI 49008-2590
For Additional Information Contact Sarah Rickert
616-385-4466
Manufacturer Reason
for Recall		 The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain.
FDA Determined
Cause 2		 Error in labeling
Action Urgent Medical Device Recall letters sent to Richard Allan distributors and customers. The recall notification includes the reason for the voluntary recall, risk to health, product information and actions to be taken by the distributor/customer.
Quantity in Commerce 132
Distribution US, Canada and Europe
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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