Recall Z-1800-2018 ยท DJG Enzyme Immunoassay, Opiates
Siemens Healthcare Diagnostics, Inc.
Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
| Date | Mar 12, 2018 |
| Status | Terminated |
| 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. |
| Distribution | PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102779 | EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C Siemens Healthcare Diagnostics, Inc., Mar 18, 2011 |