Recall Z-1403-2021— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1403-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-05

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2021-03-05. It names 2 FDA 510(k) clearances: K162977, K102644. Product: ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11. Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-03-05
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

2 on FDA's record

K162977 — ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics·cleared 2017-08-11
K102644 — ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120ISiemens Healthcare Diagnostics·cleared 2011-11-23

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

ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

Reason for recall

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

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