- Recalling firm
- BD KIESTRA LAB AUTOMATION
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
- Units affected
- 82 units (7 US, 65 OUS)
- 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;
- Firm location
- Drachten, Netherlands
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1658-2026
- Recall initiated
- February 6, 2026
- FDA classification date
- March 27, 2026
- FDA report date
- April 8, 2026
- FDA event ID
- 98473
- Last updated on HTM Vibe
- July 24, 2026