Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1015-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Dimension Vista 1500, Analyzer, chemistry Model no. 10444801

Product Classification:

Class II

Date Initiated: December 12, 2018

Date Posted: March 27, 2019

Recall Number: Z-1015-2019

Event ID: 81955

Reason for Recall:

When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination.

Status: Terminated

Product Quantity: 5373

Code Information:

Millipore lot number: F7MA50339 F7MA56608 F7NA62488 F8AA13966 F8AA93567 F8BA20457 F8BA35774 F8DA59251 F8HA64477 F8HA79819 F8HA91305 F8JA97876 F8MA06374

Distribution Pattern:

Nationwide domestic distribution. Worldwide foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated