FDA Medical devices recall · August 12, 2026

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN… recall

Read the official FDA notice ↗

Product

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

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI-DI 00842768014321 Lot U2

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.

States: California Idaho Illinois Indiana Massachusetts Mississippi North Carolina New Mexico New York Ohio Oklahoma Oregon Pennsylvania Washington

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (medical devices), recall Z-2881-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.