V8 Immunodisplacement Kit REF 1803 — Class II medical device recall Z-1244-2022
Ongoing recall by Helena Laboratories, Corp., reported 2022-06-15, distributed in FL, MO, OH, TX. Due to microbial growth causing interference with interpretation.
| Recall number | Z-1244-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Corp., Beaumont, TX, United States |
| Recall initiated | 2022-04-06 |
| Classified | 2022-06-07 |
| Reported by FDA | 2022-06-15 |
| Distributed | FL, MO, OH, TX |
| Countries outside the US | CA, UY, VN |
| Quantity | 51 kits |
| Reason classes | microbial contamination |
| Lot numbers | 1-22-1803, 3-21-1803 |
| Model numbers | 1803 |
Product
V8 Immunodisplacement Kit REF 1803
Reason for recall
Due to microbial growth causing interference with interpretation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1244-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.