Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 4/21/2021
Class II

PRODUCT

ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) – US, automated hematology analyzer Software Versions 6.10 and 6.11

Recall Number: Z-1386-2021

REASON

Potential Sample Identification (SID) Mismatch with 14-Character Barcodes.

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc. on 3/5/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

NA

DISTRIBUTION

U.S. Nationwide and International