United StatesSyva EMIT 2000 Quinidine Assay (REF 4Q019UL, contents 1 x 28 mL and 1 x 14 mL) and Beckman Coulter Emit 2000 Quinidine Assay (REF OSR4Q229, R1: 2 x 23 mL; R2: 2 x 13 mL) are affected; identified lots include 2597, 2627, 2709 with UDIs 00842768001048 and 00842768023293. The products were recalled due to unacceptable precision that may cause erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life‑threatening cardiac arrhythmias or inadequate antimalarial therapy.
What's being recalled
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Recalling firm: Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States.
How to identify it
Lot U1/UDI: 00842768001048 Lots: 2597, 2627, 2709/UDI: 00842768023293
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)