Siemens Healthcare Diagnostics, Inc.: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

Hazard

Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

Details from the source

Reason for recall: Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated. Distribution: Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan. Quantity: 8 US; 44 OUS Lot/code info: UDI-DI 00842768001406 Lot U1

UPC codes

00842768001406

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.