Z-2881-2026Class III

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

Name: Z-2881-2026 Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
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 tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL on 2026-06-26. FDA classified it as Class III and gives the reason as "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...". 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-2881-2026
Classification: Class III
Status: Open, Classified
Initiated: 2026-06-26
Posted: 2026-08-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Product code: LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On 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 commerce: 494 US; 114 OUS
Distribution: Worldwide - 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.
Product codes and lots: UDI-DI 00842768014321 Lot U2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2881-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2881-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-04

Product code LFG

K821743Class IIEmit-Tox Serum Tricyclic Antidepr. AssaySyva Co. / cleared 1982-07-02

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)