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Siemens Healthcare Diagnostics, Inc.: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

Medical DevicesSource: FDA (device) · Date: 2026-08-26

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Siemens Healthcare Diagnostics, Inc.
Product
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
Recall initiated
2026-07-13
Code info
Lot U1/UDI: 00842768001048
Product quantity
20 units
Voluntary mandated
Voluntary: Firm initiated
City
East Walpole
State
MA
Country
United States
Event id
99446
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