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Open, Classified

Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

FDA Recall Z-2976-2026 · Posted 2026-08-17

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeLBZ
Date Initiated2026-07-13
Product Quantity55 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Worldwide - US Nationwide distribution in the state of CA and the country of Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc. · 2001-06-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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