FDA Device recall Z-1334-2022
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
- FDA Device
- Class II
- ongoing
- Published 2022-07-13
On 2022-07-13 the FDA classified a Class II recall of Verigene CDF Nucleic Acid Test, Part No. 30-002-22 by Luminex, citing there is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1334-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-17 |
| Published | 2022-07-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | US |
Product
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Reason
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Identifiers
| code_info | UDI 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870; Luminex Lot Number 0713210…UDI 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870; Luminex Lot Number 071321022F, FLOQ Swab Lot Numbers: 2100856, 2107946; Luminex Lot Number 100421022A, FLOQ Swab Lot Numbers: 2110850; Luminex Lot Number 110221022E, FLOQ Swab Lot Numbers: 2107946. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1334-2022%22
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