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Recall Observatory FDA recall evidence

Device product

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

Z-1799-2018

March 12, 2018

Class III

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 79699
Status
Terminated
Classification
Class III
Quantity
N/A
Official record key
device-enforcement:Z-1799-2018

Official wording

Reason: Incorrect calibrator level listed in qualitative calibration steps

Code information: All lots

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect calibrator level listed in qualitative calibration steps