The Recall Desk
HighFDA (Devices)·Z-2332-2021·Announced 2021-09-01

Laboratory Data Management Software Recalled for Potential Patient Result Errors

Beckman Coulter's Normand Remisol Advance Data Manager software versions 2.0 and 2.1 may add extra cells to patient requests, potentially causing erroneous patient results in clinical laboratories.

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: FDA Class II medical device with a theoretical hazard where the system may produce erroneous patient results in clinical laboratories. This qualifies as a risk-of-harm product where injury has not yet been reported, fitting Score 3 per the rubric's stated criterion.

Plain-English summary

Beckman Coulter Inc. is recalling the Normand Remisol Advance Data Manager software versions 2.0 and 2.1 (reference numbers C69412, C69413, C44703, and C57017). This software device interfaces between laboratory information systems and laboratory instruments. Approximately 180 units have been distributed worldwide across multiple locations in the United States and other countries.

The data management system may add additional cells to patient requests, which could lead to erroneous patient results.

The recall affects clinical laboratories and healthcare facilities in the United States and multiple countries worldwide that use the affected software versions.

Users of Normand Remisol Advance Data Manager versions 2.0 and 2.1 should contact Beckman Coulter Inc. for guidance regarding this recall.

The recalled product

Product
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Software
Hazard
  • patient-result-error
  • data-integrity

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)

  • Software Version 2.0 and 2.1

Distribution

Distributed nationwide across the United States.

Related recalls

Same category