Recall – Hematology analyzer barcode identification mismatch

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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