Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0581-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Atellica CH 930 Analyzer

Product Classification:

Class II

Date Initiated: September 23, 2019

Date Posted: December 4, 2019

Recall Number: Z-0581-2020

Event ID: 83946

Reason for Recall:

Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

Status: Terminated

Product Quantity: 1432

Code Information:

SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163

Distribution Pattern:

Distributed to accounts located in AL AZ AR CA CO FL GA IL IN IA KS KY LA MA MI MN MS NE NV NH NJ NM NY NC OH OR PA SC TN TX UT WA WV DC PR. Foreign distribution to AR AU AT BS BD BE BR BG CA CL CO CW CZ DK EG FI FR DE GR HU IN IR IE IL IT JP KW LV MY MX NL NG NO CN PK PH PL PT QA KR RO RU SA SG SK ZA ES SE CH TW TH TR AE GB UY VN.

Voluntary or Mandated:

Voluntary: Firm initiated