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U.S. Department of Health and Human Services

Class 2 Device Recall EnVision FLEX, Mouse, High pH (Link)

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 Class 2 Device Recall EnVision FLEX, Mouse, High pH (Link)see related information
Date Initiated by FirmJuly 06, 2016
Create DateAugust 03, 2016
Recall Status1 Terminated 3 on October 13, 2016
Recall NumberZ-2330-2016
Recall Event ID 74608
Product Classification Reagent, general purpose - Product Code LDT
ProductEnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Code Information K8002 Lot no: 10112879 K8004 Lot no: 10111463
FEI Number 3002806778
Recalling Firm/
Manufacturer		 Dako Denmark A/S
Produktionsvej 42
Glostrup Denmark
Manufacturer Reason
for Recall		The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
FDA Determined
Cause 2		Process control
ActionA recall notification letter dated 7/6/16 was sent to customers to inform them that Dako is recalling EnVision FLEX+ kit because the pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. The letter informs the customers that with a pH of 4-5 instead of pH 9 there could be weak staining, false negative or false positive non-specific staining depending on the antibody used. There is the possibility that this staining could lead to a false result. Customers are to discard the affected product, determine the impact as instructed, and confirmed that they have received replacement kits. Customers are instructed to complete the Device Recall Form and contact local sales representative for any questions regarding the recall notification.
Quantity in Commerce147 kits
DistributionWorldwide Distribution -- US, Canada, and Colombia.
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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