Recalls / —
—#163063
Product
Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
- FDA product code
- DJG — Enzyme Immunoassay, Opiates
- Device class
- Class 2
- Medical specialty
- Clinical Toxicology
- 510(k) numbers
- K102779
- Affected lot / code info
- All lots
Why it was recalled
Incorrect calibrator level listed in qualitative calibration steps
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 511 Benedict Ave, Tarrytown, New York 10591-5005
Distribution
- Distribution pattern
- PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign
Timeline
- Recall initiated
- 2018-03-12
- Terminated
- 2020-06-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #163063. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.