FDA DevicesClass II
BD Kiestra" ReadA; Catalog No.: 446948.
Published: April 8, 2026Recall ID: Z-1658-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
BD Kiestra" ReadA; Catalog No.: 446948.
Affected Products
BD Kiestra" ReadA; Catalog No.: 446948.
Additional Source Details
| Field | Value |
|---|---|
| City | Drachten |
| Event id | 98473 |
| Address 1 | Marconilaan 6 |
| Code info | Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All; |
| Postal code | N/A |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 82 units (7 US, 65 OUS) |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260206 |
| Initial firm notification | Letter |
| Center classification date | 20260327 |
Overview
- Recalling FirmBD KIESTRA LAB AUTOMATION
- StatusOngoing
- Risk LevelClass II
- DistributionDomestic: 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;