Z-1658-2026 Class II Ongoing
FDA device recall Z-1658-2026 was initiated by BD KIESTRA LAB AUTOMATION on February 6, 2026 and is designated Class II. 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 ret… The recall status is ongoing. Affected quantity: 82 units (7 US, 65 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2026
- Initiation Date
- February 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82 units (7 US, 65 OUS)
Product Description
BD Kiestra" ReadA; Catalog No.: 446948.
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.
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;
Code Information
Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;