Recall Z-1244-2022 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Helena Laboratories, Corp.
V8 Immunodisplacement Kit REF 1803
| Date | Apr 6, 2022 |
| Status | Open, Classified |
| 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 remov |
| Quantity | 51 kits |
| Distribution | U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111369 | THE HELENA V8 IMMUNODISPLACEMENT KIT Helena Laboratories Uk, Ltd., Jun 26, 2012 |