Recall Z-1658-2026 ยท JTQ Bath, Incubators/Water, All
BD KIESTRA LAB AUTOMATION
BD Kiestra" ReadA; Catalog No.: 446948.
| Date | Mar 27, 2026 (initiated Feb 6, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On February 6, 2026 customers were contacted via phone call with a follow-up URGENT: Medical Device Correction letter were sent to customers on or about March 10, 2026. Actions to be taken: 1. Ensure the contents of this notification are read and understood. 2. Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge you |
| Quantity | 82 units (7 US, 65 OUS) |
| 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; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.