Helena Laboratories, Corp.: Medical Device Recall in 2022 - (Recall #: Z-1244-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

V8 Immunodisplacement Kit REF 1803

Product Classification:

Class II

Date Initiated: April 6, 2022

Date Posted: June 15, 2022

Recall Number: Z-1244-2022

Event ID: 90060

Reason for Recall:

Due to microbial growth causing interference with interpretation.

Status: Ongoing

Product Quantity: 51 kits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated