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U.S. Department of Health and Human Services

Class 3 Device Recall Syva Emit tox Serum Tricyclic Antidepressant

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 Class 3 Device Recall Syva Emit tox Serum Tricyclic Antidepressantsee related information
Date Initiated by FirmJune 26, 2026
Date PostedAugust 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2881-2026
Recall Event ID 99381
510(K)NumberK821743 
Product Classification Radioimmunoassay, tricyclic antidepressant drugs - Product Code LFG
ProductSyva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Code Information UDI-DI 00842768014321 Lot U2
FEI Number 1219913
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
For Additional Information ContactLouise Mclaughlin
508-668-5000
Manufacturer Reason
for Recall		out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. 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 June 26, 2026, the firm began notifying customers via Urgent Medical Device Correction letters. Customers were informed of the issue and provided with revised Safety Data Sheets (SDS) specific to the impacted lots for handling and disposal information.
Quantity in Commerce494 US; 114 OUS
DistributionWorldwide - US Nationwide distribution in the states CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands part of USA and the countries of Canada, South Africa, Brazil, Chile, Colombia.
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 = LFG
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