Recall Z-1800-2018
Siemens Healthcare Diagnostics, Inc. · initiated March 12, 2018
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
Codes / lots: All lots
Reason for recall
Incorrect calibrator level listed in qualitative calibration steps
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1800-2018
- Initiated
- March 12, 2018
- Terminated
- June 2, 2020
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Distribution
- PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1799-2018 Class III | Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483Incorrect calibrator level listed in qualitative calibration steps | 03/12/2018Terminated |