Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling the Syva EMIT 2000 Quinidine Assay (REF: 4Q019UL) due to precision performance problems in certain lots that may cause quinidine measurements to read erroneously high. This faulty measurement could lead to inadequate patient treatment and poses risks including potential life-threatening cardiac arrhythmias or insufficient antimalarial therapy. The affected product is Lot U1 with UDI 00842768001048, and 20 units were distributed worldwide, including nationwide distribution in California and in Italy.
The recall notice does not specify a remedy or recommended action for consumers or healthcare providers who may have this product.
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: 20 units Lot/code info: Lot U1/UDI: 00842768001048
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.