Recall Z-2881-2026 ยท LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Siemens Healthcare Diagnostics, Inc.
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
| Date | Aug 4, 2026 (initiated Jun 26, 2026) |
| Status | Open, Classified |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K821743 | EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY Syva Co., Jul 2, 1982 |