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