V8 Immunodisplacement Kit REF 1803
- Company
- Helena Laboratories, Corp.
- Recall Initiated
- April 6, 2022
- Recall Number
- Z-1244-2022
- Quantity
- 51 kits
- Firm Location
- Beaumont, TX
Reason for Recall
Due to microbial growth causing interference with interpretation.
Distribution
U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
Lot / Code Info
Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803
Root Cause
Unknown/Undetermined by firm
Action Taken
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.