Beckman Coulter Emit 2000 Quinidine Assay Recall
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Siemens Healthcare Diagnostics, Inc. is recalling 55 units of the 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 Beckman Coulter Emit 2000 Quinidine Assay after certain lots exhibited unacceptable precision performance. This 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.
Which Products Are Affected
- Product: Beckman Coulter, Emit 2000 Quinidine Assay
- REF: OSR4Q229
- Contents: R1: 2 x 23 mL; R2: 2 x 13 mL
- UDI: 00842768023293
- Lots: 2597, 2627, 2709
- Quantity: 55 units
- Distribution: US Nationwide (including California) and Italy
- Recall Number: Z-2976-2026
- Classification: Class II
What You Should Do
Consumers and healthcare providers should follow instructions provided in the firm's notification letter regarding the affected lots.
Why This Matters
The recall affects a diagnostic assay used in patient treatment decisions, with potential risks including life-threatening cardiac arrhythmias from sub-optimal quinidine therapy.
Source
FDA Enforcement Report, recall number Z-2976-2026, report date 20260826.
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 (1,177 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.