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Terminated

Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483

FDA Recall Z-1799-2018 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeDJG
Date Initiated2018-03-12
Date Terminated2020-06-02

Reason for Recall

Incorrect calibrator level listed in qualitative calibration steps

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.

Root Cause

Under Investigation by firm

Distribution Pattern

PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102779EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY CSiemens Healthcare Diagnostics, Inc. · 2011-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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