Z-2976-2026 Class II Ongoing
FDA device recall Z-2976-2026 was initiated by Siemens Healthcare Diagnostics, Inc. on July 13, 2026 and is designated Class II. 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 patien… The recall status is ongoing. Affected quantity: 55 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- July 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 units
Product Description
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
Code Information
Lots: 2597, 2627, 2709/UDI: 00842768023293