Beckman Coulter recalls Emit 2000 Quinidine Assay kits with specific lot numbers due to potential for inaccurate quinidine measurements, risking suboptimal patient treatment and possible life-threatening cardiac issues.
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.
“Beckman Coulter Emit 2000 Quinidine Assay Recall: Risk of Incorrect Patient Treatment.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697884-beckman-coulter-emit-2000-quinidine-assay-recall-risk-of-incorrect. Based on FDA recall #Z-2976-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2976-2026%22&limit=1).
Siemens Healthcare Diagnostics, Inc. recalled Beckman Coulter Emit 2000 Quinidine Assay kits worldwide on July 13, 2026, according to the FDA. The recall addresses unacceptable precision that may cause erroneously elevated quinidine measurements.
How to tell if you have it
Brand: Beckman Coulter
Product: Emit 2000 Quinidine Assay
REF: OSR4Q229
Contents: R1: 2 x 23 mL; R2 2x13 mL
Lots: 2597, 2627, 2709
UDI: 00842768023293
The hazard
The Emit 2000 Quinidine Assay may exhibit unacceptable precision performance in certain lots, leading to erroneously elevated quinidine measurements. This error creates a risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Healthcare Syva Emit Disopyramide Assay Recall (June 26, 2026), Beckman Coulter DxH Diluent Recall (Nov. 10, 2025), and Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026).
How to tell if you have this one
Check the lot numbers on the kit: 2597, 2627, or 2709. The product has a unique identifier (UDI) starting with 00842768023293. These kits were sold with specific reference numbers.
Brand
Beckman Coulter
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
Look for lot numbers 2597, 2627, or 2709 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the state of CA and the country of Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2976-2026 (July 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2976-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.