DeviceSignal · Recall classified
Siemens Healthcare Diagnostics, Inc.
FDA classified a device recall on 2026-08-17 · Class II · Z-2975-2026
EventRecall classified
Effective2026-08-17
ClassificationClass II
On 2026-08-17 the FDA classified a device recall from Siemens Healthcare Diagnostics, Inc. as Class II. Product: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL. Recall Z-2975-2026. The firm initiated it on 2026-07-13. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2975-2026
- Classification
- Class II
- Classified on
- 2026-08-17
- Initiated on
- 2026-07-13
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Reason
- Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
- Product
- Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
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-2975-2026- 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
0dd4c40d94e2b130f0dbaa821040cfe1323e4b9bf3594ef2746db13635af8cd4- 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)