United StatesBD Kiestra ReadA automated system (Catalog No. 446948, UDI‑DI 00382904469481, all serial numbers) is being recalled. BD Kiestra Lab Automation recalled it because after a system reboot one or more modules may become unreachable via the remote connectivity interface, potentially causing intermittent delays in plate retrieval from the incubator; the issue did not affect test results, assay performance, or sample integrity.
What's being recalled
BD Kiestra" ReadA; Catalog No.: 446948.
Recalling firm: BD Kiestra Lab Automation, Drachten, Netherlands.
How to identify it
Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
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;
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)