DeviceSignal · Recall classified
Diagnostica Stago, Inc.
FDA classified a device recall on 2026-08-28 · Class II · Z-3047-2026
EventRecall classified
Effective2026-08-28
ClassificationClass II
On 2026-08-28 the FDA classified a device recall from Diagnostica Stago, Inc. as Class II. Product: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074…. Recall Z-3047-2026. The firm initiated it on 2026-07-29. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3047-2026
- Classification
- Class II
- Classified on
- 2026-08-28
- Initiated on
- 2026-07-29
- Firm
- Diagnostica Stago, Inc.
- Reason
- A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
- Product
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
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-3047-2026- Snapshot hash
2ad9ab6cbee6c5eb2f0d4298731a8c9755893d917528d78bf00a015fa69a0494- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
b9f15e13e79f62b26cce6ac08043599d38e9b05101e186599cd64ba2e1335272- 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)