DeviceSignal · Recall classified
Healthmark Industries Co., Inc.
FDA classified a device recall on 2026-08-26 · Class II · Z-3032-2026
EventRecall classified
Effective2026-08-26
ClassificationClass II
On 2026-08-26 the FDA classified a device recall from Healthmark Industries Co., Inc. as Class II. Product: healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein…. Recall Z-3032-2026. The firm initiated it on 2026-07-29. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3032-2026
- Classification
- Class II
- Classified on
- 2026-08-26
- Initiated on
- 2026-07-29
- Firm
- Healthmark Industries Co., Inc.
- Reason
- Test manufactured with an expired ingredient which may present as either a false negative or positive.
- Product
- healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3032-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
44362a217c2bdf3fe2983ac9717e58477fce431e5cde151ae5c160f2e211e633- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)