Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIOngoing
Summary: Siemens Healthcare Diagnostics, Inc. is recalling Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL. 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.
What is being recalled
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the state of CA and the country of Italy. (states named: California)
How to tell if yours is affected
Lot U1/UDI: 00842768001048
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2975-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 13, 2026 |
| Reported | August 26, 2026 |
| Company | Siemens Healthcare Diagnostics, Inc. |
| Company location | East Walpole, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 20 units |
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