Official recall record
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-07-13
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00842768001048
- Brand on record
- Siemens Healthcare Diagnostics, Inc.
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-17.
Record last checked against the registry on 2026-09-17.
Other recalls from this brand
- 2026-07-13 · US FDA — Medical Devices
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL - 2026-07-06 · US FDA — Medical Devices
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic - 2026-06-26 · US FDA — Medical Devices
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
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