CLASS III Device recall · Reported 16 May 2018 · FDA Enforcement Report

Syva¿ EMIT¿ II Plus 6-Acetylmorphine recalled

Siemens Healthcare Diagnostics is recalling Syva¿ EMIT¿ II Plus 6-Acetylmorphine, distributed in 9 states. The recall was initiated on 12 Mar 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesAll lots

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1799-2018
FDA event ID: 79699
Recalling firm: Siemens Healthcare Diagnostics, Tarrytown, NY
Classification: Class III
Status: Terminated
Recall initiated: 12 Mar 2018
FDA classified: 10 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Mar 2018	Recall initiated by company
10 May 2018	Classified by FDA	+59 days
16 May 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect calibrator level listed in qualitative calibration steps

Product as listed by the FDA

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

Where it was distributed

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

Florida Kansas Kentucky Massachusetts Maine New Hampshire Pennsylvania Texas Utah

Questions about this recall

Why was it recalled?

Incorrect calibrator level listed in qualitative calibration steps

Which lots are affected?

All lots

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 79699

This product is part of a recall event; the main page for the event is Syva¿ EMIT¿ II Plus 6-Acetyl morphine recalled.

Reported	Class	Recall	Company	Reason	Where
16 May 2018	CLASS III	Syva¿ EMIT¿ II Plus 6-Acetyl morphine recalled	Siemens Healthcare Diagnostics	Other	9 states

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