Siemens syngo Lab Data Manager Software Recall for Auto-verification Failures
Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager software versions VA11B and VA12A because the system may release results that require manual review or delay result transmission.
What this means for you
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 FDA classified this as a Class II recall. The hazard involves the potential release of results that require manual review or the delay of result transmission, which poses a risk of harm to patients but is not classified as a Class I (reasonable probability of serious adverse health consequences) or associated with reported fatalities.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling syngo(R) Lab Data Manager software, specifically versions VA11B and VA12A. The recall involves 262 units distributed nationwide in the United States and internationally to Canada.
The recall is issued because, under certain conditions, the system may not perform as intended. This malfunction can cause the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules. Additionally, the system may delay or omit the transmission of results to the LIS.
The affected products are identified by Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A). The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 262
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 (1)
- Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)
Distribution
Distributed nationwide across the United States.
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