FDA Class II Recall of Siemens Beckman Coulter Quinidine Assay Kits: Check Your Lots
The FDA has classified the recall of certain lots of the Emit 2000 Quinidine Assay as Class II, and is urging users to check their inventory against the listed lots and UDI.
2 reports on this incident · first at Sep 7, 2026, 9:19 p.m. ET
Earlier reports
Sep 7, 2026, 9:19 p.m. ETFirst report
FDA Class II Recall Issued for Siemens Beckman Coulter Quinidine Assay Kits
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for certain lots of the Beckman Coulter Emit 2000 Quinidine Assay, a diagnostic reagent kit used to measure quinidine levels in blood samples. The recall, initiated on July 13, 2026, and reported on August 26, 2026, affects 55 units distributed nationwide in the U.S. and in Italy, according to the FDA enforcement report (recall number Z-2976-2026).
The affected product is identified as Beckman Coulter Emit 2000 Quinidine Assay, REF OSR4Q229, with identifying codes: Lots: 2597, 2627, 2709/UDI: 00842768023293. The recall was issued because certain lots exhibited unacceptable precision performance, which may lead to erroneously elevated quinidine measurements. This could result in sub-optimal patient treatment, including potential cardiac arrhythmias or inadequate antimalarial therapy, according to the FDA report.
The FDA classifies this as a Class II recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote, per the FDA's recall definitions. The recall is ongoing. The FDA database records no other enforcement actions by Siemens Healthcare Diagnostics, Inc., the firm listed as the responsible party. The product is an in vitro diagnostic reagent kit used in professional laboratories, according to product information from Thermo Fisher Scientific and FDA sources.
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- Version 18 Sept 2026, 01:19current
First published.
- Version 18 Sept 2026, 01:24current
First published.
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