Helena Laboratories, Corp. V8 Immunodisplacement Kit REF 1803 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
V8 Immunodisplacement Kit REF 1803
Brand
Helena Laboratories, Corp.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803
Helena Laboratories, Corp. is recalling V8 Immunodisplacement Kit REF 1803 due to Due to microbial growth causing interference with interpretation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to microbial growth causing interference with interpretation.
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, MO, OH, TX
Page updated: Jan 10, 2026