Siemens Healthcare Diagnostics, Inc. recalls Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 C
See all recalls from Siemens Healthcare Diagnostics, Inc. →Recalled Product
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lots: 2597, 2627, 2709/UDI: 00842768023293
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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