Agency classClass IIOur severity:High FDA (Devices)·Z-2305-2012·Announced 2012-09-12

Siemens syngo Lab Data Manager Recall for Quality Control Defect

Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager and Process Manager software due to a defect that may prevent the system from flagging quality control violations appropriately.

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 risk-of-harm product where the defect could lead to unheld patient results, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. The affected software is classified as a data calculator and processing module used with in-vitro diagnostic devices to provide workflow management and remote instrument control. The recall covers 44 units distributed nationwide in the United States, including specific states such as Arizona, California, Florida, Illinois, Kentucky, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, and West Virginia.

The recall is issued because the syngo Quality Control package may not perform as intended for Multi-Rule QC violations, such as 2(2S), 4(1s), and 10x, unless configured according to specific instructions provided in the recall notification. This defect may result in QC status not being flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results may not be held as expected.

Healthcare facilities using these devices should contact Siemens Healthcare Diagnostics for further instructions on how to configure the system correctly to ensure proper quality control flagging.

The recalled product

Product: syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — Laboratory Software
Hazard: software-defect
quality-control-failure
Affected units: 44

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)

Version VA11B and all previously released versions.

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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