FDA Device recall Z-1244-2022
V8 Immunodisplacement Kit REF 1803
- FDA Device
- Class II
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of V8 Immunodisplacement Kit REF 1803 by Helena Laboratories, citing due to microbial growth causing interference with interpretation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1244-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-06 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Helena Laboratories |
| Distribution | FL, MO, OH, TX |
Product
V8 Immunodisplacement Kit REF 1803
Reason
Due to microbial growth causing interference with interpretation.
Identifiers
| 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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All Helena Laboratories recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1244-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.