Recall – Immunoassay analyzer settings can be corrupted

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 5/7/2020
Class II

PRODUCT

Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower

Recall Number: Z-1797-2020

REASON

Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc. on 2/27/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1807

DISTRIBUTION

US Nationwide and International

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.