V8 Immunodisplacement Kit REF 1803
FDA Recall Z-1244-2022 · Posted None
Recalling FirmHelena Laboratories, Corp.
Recall StatusOpen, Classified
Product CodeCFF
Date Initiated2022-04-06
Product Quantity51 kits
Reason for Recall
Due to microbial growth causing interference with interpretation.
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 [email protected] or 1-800-231-5663 extension 1600.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.