FDA Device recall Z-3031-2026
healthmark ProChek-II, Model Number PT-313, PT-201-12
- FDA Device
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of healthmark ProChek-II, Model Number PT-313, PT-201-12 by Healthmark Industries, citing test manufactured with an expired ingredient which may present as either a false negative or positive.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3031-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-29 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Healthmark Industries |
| Distribution | US |
Product
healthmark ProChek-II, Model Number PT-313, PT-201-12
Reason
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Identifiers
| code_info | PT-313 - Serial/Lot Numbers: 3000535312, 3000535333, 3000536416, 3000536423, 3000537810, 3000537822, 3000542453, 30005…PT-313 - Serial/Lot Numbers: 3000535312, 3000535333, 3000536416, 3000536423, 3000537810, 3000537822, 3000542453, 3000545623, 3000550099, 3000550512, 313069, 313072, 313073, 313074, 313075, 313076, 313077, 313078, 313079, 313080, 313081, 313082, 313083, 313084, 313085, 313086, 313087, 313088, 313089, 313090, 313091, 313092, 313093, 313094, 313095, 313096, 313097, 313098, 313099, 313100, 313101, 313102, 313106, 313107; H-PT-201-12 - Serial/Lot Numbers: 7P0110, 7P0111, 7P0113, 7P0122. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3031-2026%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.