Siemens Healthcare Diagnostics, Inc. Atellica CH 930 Analyzer Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AL, AZ, AR, CA, CO, DE, 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