Recall Z-1014-2019— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1014-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-12

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-12-12, terminated 2020-04-27. It names one FDA 510(k) clearance: K051087. Product: Dimension Vista 500, Analyzer, chemistry Model no. 10284473. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-12-12
Terminated: 2020-04-27
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K051087 — DIMENSION VISTA INTEGRATED SYSTEMDade Behring, Inc.·cleared 2005-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Dimension Vista 500, Analyzer, chemistry Model no. 10284473

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.