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U.S. Department of Health and Human Services

Class 3 Device Recall BioGenex Super Sensitive LinkLabel IHC Detection System

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 Class 3 Device Recall BioGenex Super Sensitive LinkLabel IHC Detection Systemsee related information
Date Initiated by FirmOctober 03, 2006
Date PostedDecember 08, 2006
Recall Status1 Terminated 3 on December 04, 2007
Recall NumberZ-0217-2007
Recall Event ID 36514
Product Classification ICH Detection Kit - Product Code NJT
ProductSuper Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.
Code Information Catalog Number QP300-XAK, Lot numbers QP3000905B, QP3000905C, QP3001205B, QP3001005, QP3001205, QP3000206, QP3001205C, QP3000506, QP3000506B, QP3000506C, QP3000606, QP3000706.
FEI Number 2936532
Recalling Firm/
Manufacturer		 Biogenex Laboratories
4600 Norris Canyon Road
San Ramon CA 94583-1320
Manufacturer Reason
for Recall		Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as '1 x 100 mL Alk Phos Label' which should read '1 x 100 mL HRP Label'. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which should be labeled as "RTU MultiLink HPR". The reagent vials in the box are correctly labeled.
FDA Determined
Cause 2		Other
ActionThe firms provided written notificaiton letter on approximately 10/03/06, which includes a ''reply back form'' which the firm has requested to be sent back to them. The firm has asked distributors to inform their accounts of the correction, in the event that the product has been shipped out to customers.
Quantity in Commerce158 units
DistributionWorldwide-USA (including VA Medical Center) and Greece, Jordan, France, India, Taiwan, United Kingdom, Turkey, and Italy
Total Product Life CycleTPLC 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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