BD KIESTRA LAB AUTOMATION — BD Kiestra" ReadA; Catalog No.: 446948.
⚠️ 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.
Is this relevant to me?
- Geography
- KS, MD, MN, NJ, TX, VA
- Source agency
- FDA
- Category
- Health
- Published
- February 6, 2026
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;
What's affected?
- Product
- BD Kiestra" ReadA; Catalog No.: 446948.
- Lot code
- Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
Additional details
Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 82 units (7 US, 65 OUS).
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