Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1799-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: March 12, 2018

Date Posted: May 16, 2018

Recall Number: Z-1799-2018

Event ID: 79699

Reason for Recall:

Incorrect calibrator level listed in qualitative calibration steps

Status: Terminated

Product Quantity: N/A

Code Information:

All lots

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated