Z-0581-2020Class II

Atellica CH 930 Analyzer

Name: Z-0581-2020 Atellica CH 930 Analyzer
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-09-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-09-23 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH 930 Analyzer on 2019-09-23. FDA classified it as Class II and gives the reason as "Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0581-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-23
Posted: 2019-11-27
Terminated: 2022-07-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH 930 Analyzer
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued an Urgent medical Device Correction, (UMDC ASW19-06.A.US) and Urgent Field Safety Notification (UFSN ASW19-06.A.OUS) to all affected Customers via Certified Mail (domestic) and e-mail (international) beginning on 2019-09-23. It included the following instructions to the user: Actions to be Taken by the Customer 1. Do not order Reagent Pack Calibration (C0 Adjust) while the Reagent Lot calibration is in progress. 2. Always run QC after calibration before running patient samples. If QC is ordered with calibration and it recovers out of range high, the calibration status will be 'Awaiting Acceptance'. Reject and re-order the calibration. - Please review this letter with your Medical Director. - Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. - If you have received any complaints of illness or adverse events associated with the product listed immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
Quantity in commerce: 1432
Distribution: 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.
Product codes and lots: SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0581-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0581-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-27

Product code JJE

K151767Class IITrinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP CalibratorSiemens Healthcare Diagnostics, Inc. / cleared 2015-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)