FDA recall, , Moderate risk
Siemens Healthcare Diagnostics Beckman Coulter and Syva EMIT 2000 Quinidine Assay
The Syva EMIT 2000 Quinidine Assay has unacceptable precision, leading to erroneously elevated quinidine measurements.
Summary by Recall Canary from the FDA notice
What happened
Siemens Healthcare Diagnostics, Inc., of East Walpole, Massachusetts, recalled the Syva EMIT 2000 Quinidine Assay and the Beckman Coulter Emit 2000 Quinidine Assay on July 13, 2026, due to unacceptable precision performance in certain lots, which may lead to erroneously elevated quinidine measurements, creating a risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
The recall was added to the FDA's Enforcement Report on August 17, 2026, and classified by the FDA on August 17, 2026, with distribution in California and Italy.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
- UDI-DI
- 00842768023293
- Lot code
- 2597
- 2627
- 2709
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
- UDI-DI
- 00842768001048
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the state of California and the country of Italy.
- Company
- Siemens Healthcare Diagnostics, Inc.East Walpole, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99446
- Recall numbers
- Z-2975-2026 to Z-2976-2026
All recalls from Siemens Healthcare Diagnostics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
