Beckman Coulter, Emit 2000 Quinidine Assay recallZ-2976-2026 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 13, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
On July 14, 2026, Simens Healthineers issued a Urgent Medical Device Correction notification via FedEx. Simens asked consignees to take the following actions: 1. Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Discontinue use of and discard the kit lots listed in the Products Section. 3. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 4. Retain this letter with your laboratory records and forward this letter to those who may have received this product.
Recall details
- Recall number
- Z-2976-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 13, 2026
- Posted by the FDA
- Aug 17, 2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 55 units
- Product code
- LBZ
- FDA submissions
- K011605
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
Product description
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Code information (models, lots, serial numbers)
Lots: 2597, 2627, 2709/UDI: 00842768023293
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Emit® 2000 Quinidine Assay 10445329Siemens Healthcare Diagnostics Inc. · ENZYME IMMUNOASSAY, QUINIDINE1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99446).
- Z-2975-2026 · Open, ClassifiedSyva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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