Recall Z-1587-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1587-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-26

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-02-26, terminated 2020-05-12. It names one FDA 510(k) clearance: K161954. Product: Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.. Reason: When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-02-26
Terminated: 2020-05-12
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)Siemens Healthcare Diagnostics·cleared 2017-03-09

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

Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.

Reason for recall

When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

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