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U.S. Department of Health and Human Services

Class 2 Device Recall Helena V8 Immunodisplacement Kit

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 Class 2 Device Recall Helena V8 Immunodisplacement Kitsee related information
Date Initiated by FirmApril 06, 2022
Create DateJune 07, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1244-2022
Recall Event ID 90060
510(K)NumberK111369 
Product Classification Immunoelectrophoretic, immunoglobulins, (g, a, m) - Product Code CFF
ProductV8 Immunodisplacement Kit REF 1803
Code Information Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803
Recalling Firm/
Manufacturer		 Helena Laboratories, Corp.
1530 Lindbergh Dr
Beaumont TX 77707-4131
For Additional Information ContactDr. Jessica Jones Hanka
409-842-3714 Ext. 1177
Manufacturer Reason
for Recall		Due to microbial growth causing interference with interpretation.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn 04/06/2022, Helena Laboratories emailed an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that the firm is recalling V8 Immunodisplacement Kit Lots 3-21-1803, and 1-22-1803 due to visible particulate contamination in some vials of a component within the kit - the IgG antisera. Use of this product may result in an artifact anodal to albumin potentially interfering with interpretation of the IgG pattern. Customers are instructed to immediately evaluate their inventory for product subject to recall, and quarantine accordingly. All unused bottles in the field will be removed from the field, and replaced with an unaffected lot. For questions or further assistance, email or call Dr. Jessica Jones Hanka at jhanka@helena.com or 1-800-231-5663 extension 1600.
Quantity in Commerce51 kits
DistributionU.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CFF
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