Siemens Syva EMIT 2000 Quinidine Assay Recall
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Siemens Healthcare Diagnostics, Inc. is recalling 20 units of the Syva EMIT 2000 Quinidine Assay due to unacceptable precision performance that may cause erroneously elevated measurements.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 8, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Siemens Healthcare Diagnostics, Inc. initiated a voluntary recall of the Syva EMIT 2000 Quinidine Assay because certain lots exhibited unacceptable precision performance, which may lead to erroneously elevated quinidine measurements.
Which Products Are Affected
The recall affects the Syva EMIT 2000 Quinidine Assay, REF: 4Q019UL, Contents: 1x28 mL, 1x14mL. A total of 20 units are involved under Lot U1 with UDI 00842768001048. Distribution was to the United States nationwide, including the state of CA, and Italy.
What You Should Do
Consumers should contact Siemens Healthcare Diagnostics, Inc. regarding the recall. The recalling firm is located at 333 Coney St, East Walpole, MA 02032-1516.
Why This Matters
Erroneously elevated quinidine measurements create a risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
Source
FDA Recall Number Z-2975-2026 (Class II)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (978 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to September 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.