Bd Kiestra Lab Automation Marconilaan 6 Drachten Netherlands: Bath, Incubators/water, All
- Recalling firm
- BD KIESTRA LAB AUTOMATION Marconilaan 6 Drachten Netherlands
- Product
- BD Kiestra" ReadA; Catalog No.: 446948.
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-06
- Status
- Open, Classified
- Areas affected
- KS, MD, MN, NJ, TX, VA
- 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;
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/54912e71-9977-4dc8-a36a-8beba91658ff