FDA recall, , Moderate risk
BD Kiestra ReadA
The BD Kiestra ReadA can have modules unreachable after a reboot, delaying plate retrieval.
Summary by Recall Canary from the FDA notice
What happened
BD Kiestra Lab Automation, located in Drachten, Netherlands, initiated a recall of the BD Kiestra ReadA, Catalog No. 446948, on February 6, 2026. The recall was added to the FDA's Enforcement Report on March 27, 2026, and included 82 units, with 7 distributed in the United States and 65 internationally.
The recall was issued because, in certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface, potentially causing 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.
The product was distributed domestically in Kansas, Maryland, Minnesota, New Jersey, Texas, and Virginia, and internationally in Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Kuwait, Mexico, Morocco, Netherlands, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and catalog code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
BD Kiestra" ReadA
- UDI-DI
- 00382904469481
- Catalog code
- 446948.
Recall details
- Company began the recall
- Sold in
Domestic: Kansas, Maryland, Minnesota, New Jersey, Texas, Virginia; 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;
- Company
- BD KIESTRA LAB AUTOMATIONDrachten, Netherlands
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98473
- Recall number
- Z-1658-2026
- Quantity recalled
- 82 units (7 US, 65 OUS)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
