Siemens Atellica CH 930 Analyzer Recalled for Calibration Error
Siemens Healthcare Diagnostics is recalling 1,432 Atellica CH 930 Analyzers due to a potential calibration error that may cause results to be five times higher than expected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (incorrect patient results) where no specific injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,432 units of the Atellica CH 930 Analyzer. The recall is due to a potential for calibration error that can result in quality control failures after a calibration run, with quality control and patient results being five times higher than expected.
The affected units are identified by Software V1.20.0 and lower, with UDI 00630414002163. The devices were distributed to accounts in numerous US states and territories, as well as to foreign locations including Australia, Brazil, Canada, China, Germany, India, Japan, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected analyzers and contact Siemens Healthcare Diagnostics for further instructions on the recall.
The recalled product
- Product
- Atellica CH 930 Analyzer
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,432
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- SMN 11067000
- Software V1.20.0 and Lower
- UDI 00630414002163
Distribution
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