BD Kiestra" ReadA recall
BD Kiestra" ReadA; Catalog No.: 446948.
Why was BD Kiestra" ReadA recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
- Product
- BD Kiestra" ReadA; Catalog No.: 446948.
- Recalling firm
- BD KIESTRA LAB AUTOMATION
- Quantity
- 82 units (7 US, 65 OUS)
- Distribution
- 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;
- Recall date
- April 8, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)