Recall Z-2881-2026— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2881-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-26

Class III · Ongoing

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2026-06-26. It names one FDA 510(k) clearance: K821743. Product: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2026-06-26
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K821743 — EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAYSyva Co.·cleared 1982-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.