Siemens syngo Lab Data Manager Software Recall for Configuration Errors
Siemens is recalling syngo Lab Data Manager software because configuration errors may cause test results to bypass manual review and release to the Laboratory Information System.
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 is classified as FDA Class II, and the hazard involves a risk of harm (incorrect release of lab results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 336 units of syngo Lab Data Manager application software, specifically versions VA11B, VA12A, and VA12B. The affected software is associated with Service Material Numbers (SMN) 10800057, 10803189, and 10804573.
The recall was initiated because certain configuration parameters may cause reference ranges to not hold results as expected. This defect can result in test results being released to the Laboratory Information System (LIS) that should have been held for manual review.
The affected software was distributed worldwide, including in the United States, Canada, Australia, Belgium, the Czech Republic, Germany, Denmark, Finland, France, the United Kingdom, Italy, the Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain. Users of this software should contact Siemens Healthcare Diagnostics for further instructions on how to address the configuration issue.
The recalled product
- Product
- syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 336
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)
- syngo Lab Data Manager Application Software versions VA11B
- VA12A
- and VA12B
Distribution
Distributed nationwide across the United States.
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