CLASS II ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report

BD Synapsys Informatics Solution recalled by Becton Dickinson &

Becton Dickinson & is recalling BD Synapsys Informatics Solution, distributed in 15 states. The recall was initiated on 8 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00382904441500;

Quantity recalled102 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2099-2023
FDA event ID: 92406
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jun 2023
FDA classified: 5 Jul 2023
Reported: 12 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Jun 2023	Recall initiated by company
5 Jul 2023	Classified by FDA	+27 days
12 Jul 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.

Product as listed by the FDA

BD Synapsys Informatics Solution, Catalog Number 444150

Where it was distributed

US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI. Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom

California Colorado Iowa Illinois Michigan Minnesota Missouri New York Ohio Oklahoma South Carolina Tennessee Texas Utah Wisconsin

Questions about this recall

Is BD Synapsys Informatics Solution recalled?

Yes. Becton Dickinson & recalled BD Synapsys Informatics Solution on 8 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2099-2023.

Why was it recalled?

Which lots are affected?

UDI-DI: 00382904441500;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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