Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling certain lots of the Beckman Coulter Emit 2000 Quinidine Assay (REF: OSR4Q229) due to unacceptable precision performance. The affected product contains R1 (2 x 23 mL) and R2 (2 x 13 mL) components and was distributed worldwide, including nationwide in California and in Italy. A total of 55 units from Lots 2597, 2627, and 2709 (UDI: 00842768023293) are affected.
The precision problems in certain lots may cause erroneously elevated quinidine measurements, which could result in sub-optimal patient treatment. This poses a risk of potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Worldwide - US Nationwide distribution in the state of CA and the country of Italy. Quantity: 55 units Lot/code info: Lots: 2597, 2627, 2709/UDI: 00842768023293
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.