The Recall Desk
HighFDA (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.

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 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
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:

Related recalls

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

See all →

Same hazard · incorrect data

See all →