Agency classClass IIOur severity:High FDA (Devices)·Z-2173-2012·Announced 2012-08-15

Siemens syngo Lab Data Manager Recall for Incorrect Coagulation Results

Siemens is recalling 15 syngo Lab Data Manager units because they may display and transmit incorrect coagulation results to laboratory information systems.

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 that may transmit incorrect diagnostic results, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 15 units of the syngo(R) Lab Data Manager. This device is a data calculator and processing module used with in-vitro diagnostic devices, including work flow management and remote instrument control. The recall affects Version VA11B and all previously released versions.

The recall was initiated because the syngo Lab Data Manager may display and transmit incorrect results to the Laboratory Information System (LIS) when used with a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer. This error occurs following the application of the configured result number format.

The affected units were distributed nationwide in the United States, specifically in Arizona, California, Mississippi, Missouri, New Jersey, North Carolina, Ohio, Oregon, Pennsylvania, and Texas. Users should contact Siemens Healthcare Diagnostics, Inc. for instructions on how to resolve the issue.

The recalled product

Product: Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager 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 interfaced instruments
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — Laboratory Data Management
Hazard: incorrect-data
diagnostic-error
Affected units: 15

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 10 states specifically:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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