FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
- Recall number
- Z-1800-2018
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
- Status
- Terminated
- Initiated
- 2018-03-12
- Posted
- not on file
- Terminated
- 2020-06-02
- Reason
- Incorrect calibrator level listed in qualitative calibration steps
- Root cause
- Under Investigation by firm
- Action
- Siemens issued an Urgent Medical Device Correction (UMDC) in the U.S. and an Urgent Field Safety Notification (UFSN) in the OUS on 13-March-2018 to notify Syva Emit II Plus 6-Acetylmorphine customers that the calibrator on the Application Sheet is incorrect.
- Quantity
- not on file
- Distribution
- PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K102779"]
- PMA numbers
- not on file
- Product code
- DJG
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- 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