—#176794

Product

Atellica CH 930 Analyzer

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K151767
Affected lot / code info: SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

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.

Timeline

Recall initiated: 2019-09-23
Terminated: 2022-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176794. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.