FDA Medical Device Recalls (openFDA)
Helena Laboratories, Corp.: V8 Immunodisplacement Kit REF 1803
- Recall number
- Z-1244-2022
- Recalling firm
- Helena Laboratories, Corp.
- Product
- V8 Immunodisplacement Kit REF 1803
- Status
- Open, Classified
- Initiated
- 2022-04-06
- Posted
- not on file
- Terminated
- not on file
- Reason
- Due to microbial growth causing interference with interpretation.
- Root cause
- Unknown/Undetermined by firm
- Action
- 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.
- Quantity
- 51 kits
- Distribution
- U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
- Lot, serial or model codes
- Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803
- 510(k) numbers
- ["K111369"]
- PMA numbers
- not on file
- Product code
- CFF
- Firm FEI
- 1618982
- Firm city
- Beaumont
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28