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U.S. Department of Health and Human Services

Class 3 Device Recall Syva Emit Disopyramide Assay

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 Class 3 Device Recall Syva Emit Disopyramide Assaysee related information
Date Initiated by FirmJune 26, 2026
Date PostedAugust 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2880-2026
Recall Event ID 99379
510(K)NumberK801204 
Product Classification Enzyme immunoassay, lidocaine - Product Code KLR
ProductSyva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Code Information UDI-DI 00842768001406 Lot U1
FEI Number 2517506
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr
Newark DE 19702-2466
For Additional Information ContactLouise Mclaughlin
800-441-9250
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 Commerce8 US; 44 OUS
DistributionWorldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KLR
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