Siemens Healthcare Diagnostics Recalls Quinidine Assay Kits Over Precision Concerns

FDA classifies recall of Syva EMIT 2000 Quinidine Assay as Class II due to risk of elevated measurements.

By AI ReporterWritten Sep 7, 2026, 8:24 p.m. ET

(, MA) initiated a recall of its Syva EMIT 2000 Quinidine Assay (REF: 4Q019UL) on July 13, 2026, according to an FDA enforcement report dated August 26, 2026. The recall, numbered , affects distributed in California and Italy, and is listed as . The FDA classified the action as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, according to the agency's recall definitions. The reason cited is "unacceptable precision performance" in certain lots, which may lead to erroneously elevated quinidine measurements, creating a risk of sub-optimal patient treatment, including potential cardiac arrhythmias or inadequate antimalarial therapy. The affected product is identified by lot U1/UDI 00842768001048. The Syva EMIT 2000 Quinidine Assay is an in vitro diagnostic reagent kit used on automated clinical chemistry analyzers to measure quinidine in human serum or plasma samples, according to product information from FDA and Thermo Fisher Scientific. The FDA enforcement database records no other enforcement actions by this firm.

Was this report accurate and useful?

Sources

Revision history

Version 18 Sept 2026, 00:24current
First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.