Z-1244-2022Class II

V8 Immunodisplacement Kit REF 1803

Name: Z-1244-2022 V8 Immunodisplacement Kit REF 1803
Creator: Helena Laboratories, Corp.
Published: 2022-04-06
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2022-04-06 / Open, Classified

FDA source

Helena Laboratories, Corp. began a recall of V8 Immunodisplacement Kit REF 1803 on 2022-04-06. FDA classified it as Class II and gives the reason as "Due to microbial growth causing interference with interpretation". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1244-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-06
Posted: 2022-06-07
Recalling firm: Helena Laboratories, Corp.
Product: V8 Immunodisplacement Kit REF 1803
Product code: CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Reason for recall: Due to microbial growth causing interference with interpretation.
FDA 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 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.
Quantity in commerce: 51 kits
Distribution: U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
Product 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1244-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1244-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-07

Product code CFF

K111369Class IIThe Helena V8 Immunodisplacement KitHelena Laboratories Uk, Ltd. / cleared 2012-06-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)