Agency classClass IIOur severity:High FDA (Devices)·Z-2099-2023·Announced 2023-07-12

BD Synapsys Informatics Solution risks patient data mis-association

The BD Synapsys Informatics Solution may incorrectly associate patient demographic data under specific conditions when the system operates near capacity during rapid manual result processing.

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: This is a FDA Class II recall addressing a risk-of-harm product (patient data integrity in a healthcare system) where no illnesses, injuries, or deaths have been reported. Per the severity rubric, when the hazard is theoretical with no reported harm, the maximum score is 3 (High).

Plain-English summary

The BD Synapsys Informatics Solution (Catalog Number 444150) is a laboratory informatics system manufactured by Becton Dickinson & Co. Approximately 102 systems have been distributed to healthcare facilities in the United States and internationally.

There is a risk that patient demographic data may be mis-associated—linked to the wrong patient record. This risk occurs specifically when laboratory staff use manual result reporting, the Service Control Unit (SCU) operates near capacity, and rapid-processing save actions (Skip, Final Discard, Mark as Read, or Save) are used to process multiple patient results in sequence.

The affected systems are distributed in multiple U.S. states including California, Colorado, Iowa, Illinois, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Utah, and Wisconsin, as well as in Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.

The recalled product

Product: BD Synapsys Informatics Solution, Catalog Number 444150
Manufacturer: Becton Dickinson & Co.
Category: Medical Device — Laboratory Informatics
Hazard: patient-data-misassociation
Affected units: 102

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)

UDI-DI: 00382904441500

Distribution

Distributed in 15 states:

Same manufacturer · Becton Dickinson & Co.

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