Siemens Healthcare Diagnostics recall: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL and 1 more product
Siemens Healthcare Diagnostics, Inc. is recalling Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL and 1 more product – 20 units; 55 units. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 13, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL and 1 more product |
| Brand | Siemens Healthcare Diagnostics |
| Company | Siemens Healthcare Diagnostics, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 13, 2026 |
| Published by FDA | August 26, 2026 |
| Quantity | 20 units; 55 units |
| Recall ID | 99446 |
Recalled products (2)
- Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
- FDA recall number
- Z-2975-2026
- Codes, lots and dates
- Lot U1/UDI: 00842768001048
- Quantity
- 20 units
- Classification
- Class II
- Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
- FDA recall number
- Z-2976-2026
- Codes, lots and dates
- Lots: 2597, 2627, 2709/UDI: 00842768023293
- Quantity
- 55 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99446
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- East Walpole, MA, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide - US Nationwide distribution in the state of CA and the country of Italy.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99446, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Siemens Healthcare Diagnostics recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
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| Oct 7, 2026 | Beckman Coulter Mishima K.K recall: Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480…Medical devices · 492 units | Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may outpu… Serious | FDA Class II |
About this recall
Is Siemens Healthcare Diagnostics Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL recalled?
Yes. Siemens Healthcare Diagnostics, Inc. recalled it on July 13, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
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 should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.