Recall archive / FDA device enforcement
V8 Immunodisplacement Kit REF 1803 — FDA record Z-1244-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 6, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- V8 Immunodisplacement Kit REF 1803
- Reason
- Due to microbial growth causing interference with interpretation.
- Classification
- Class II
- Recalling firm
- Helena Laboratories, Corp.
- Quantity
- 51 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1244-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 15, 2022
- Recall initiation date
- Apr 6, 2022
- Center classification date
- Jun 7, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.