Z-2880-2026Class III

Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

Name: Z-2880-2026 Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2026-06-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-06-26 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL on 2026-06-26. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2880-2026
Classification: Class III
Status: Open, Classified
Initiated: 2026-06-26
Posted: 2026-08-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Product code: KLR Enzyme Immunoassay, Lidocaine
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On 6/26/2026, Siemens issued Urgent Medical Device Correction letters to all affected customers informing them of the issue and providing instructions. Customers are instructed to refer to the SDS which were created and provided with the Urgent Medical Device Corrections and the Urgent Field Safety Notices specifically for Syva Emit Disopyramide Assay Lot U1 for information regarding handling and disposal.
Quantity in commerce: 8 US; 44 OUS
Distribution: Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
Product codes and lots: UDI-DI 00842768001406 Lot U1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2880-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2880-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-04

Product code KLR

K801204Class IIEmit Disopyramide AssaySyva Co. / cleared 1980-06-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)