Device product
BD Kiestra" ReadA; Catalog No.: 446948.
Z-1658-2026
Product summary
- Event
- Event 98473
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 82 units (7 US, 65 OUS)
- Official record key
device-enforcement:Z-1658-2026
Official wording
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.
Code information: Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
Distribution pattern: 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;
Derived failure modes
-
Unknown
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.