Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer

Is my product affected?

Atellica CH 930 Analyzer

• UPC 00630414002163

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics, Inc. is recalling 1,432 Atellica CH 930 Analyzers due to a potential calibration error that can cause quality control failures after calibration runs. This error results in QC and patient test results displaying values that are approximately 5 times higher than actual levels. The affected units have software version 1.20.0 and lower with SMN 11067000 and UDI 00630414002163. The devices were distributed across multiple U.S. states, Puerto Rico, and numerous countries internationally.

The recall notice does not specify a remedy or what actions consumers should take regarding the affected analyzers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher. 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. Quantity: 1432 Lot/code info: SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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