V8 Immunodisplacement Kit REF 1803

Date

June 15, 2022

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Helena Laboratories, Corp.

Product

V8 Immunodisplacement Kit REF 1803

Reason

Due to microbial growth causing interference with interpretation.

Distribution pattern

U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,

Quantity

51 kits

Codes and lots

Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803

Recall started

April 6, 2022

Device type

Immunoelectrophoretic, Immunoglobulins, (G, A, M)

Root cause (FDA)

Unknown/Undetermined by firm

What the company told customers

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.

Recall number

Z-1244-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1244-2022. The agency record governs; check it and the company before acting.