FDA Medical devices recall ·
BD Kiestra" ReadA recall
- Recall number
- Z-1658-2026
- Date
- (initiated February 6, 2026)
- Company / brand
- Bd Kiestra Lab Automation
Marconilaan 6, Drachten, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 82 units (7 US, 65 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD Kiestra" ReadA; Catalog No.: 446948.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
Distribution
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;
States: Kansas Maryland Minnesota New Jersey Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1658-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.