BD Kiestra" ReadA recall (BD KIESTRA LAB AUTOMATION)

Medical deviceClass IIOngoing

Summary: BD KIESTRA LAB AUTOMATION is recalling BD Kiestra" ReadA; Catalog No.: 446948.. Reason: In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.

What is being recalled

BD Kiestra" ReadA; Catalog No.: 446948.

Why

In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Domestic: KS, MD, MN, NJ, TX, VA; International: Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Kuwait, Mexico, Morocco, Netherlands, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom; (states named: Kansas, Maryland, Minnesota, New Jersey, Texas, Virginia)

How to tell if yours is affected

Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from BD KIESTRA LAB AUTOMATION · all medical device recalls · recalls from February 2026

Official FDA record