[pending] BD Kiestra" ReadA; Catalog No.: 446948.
Pending LLM rewrite. Source: FDA_DEVICE Z-1658-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- BD Kiestra" ReadA; Catalog No.: 446948.
- Manufacturer
- BD KIESTRA LAB AUTOMATION
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog No.: 446948
- UDI-DI: 00382904469481
- Serial Numbers: All
Distribution
Distributed in 6 states:
- KS
- MD
- MN
- NJ
- TX
- VA
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