FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
- Recall number
- Z-2881-2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
- Status
- Open, Classified
- Initiated
- 2026-06-26
- Posted
- 2026-08-04
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI-DI 00842768014321 Lot U2
- 510(k) numbers
- ["K821743"]
- PMA numbers
- not on file
- Product code
- LFG
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28