Recall archive / FDA device enforcement
BD Kiestra" ReadA; Catalog No.: 446948. — FDA record Z-1658-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 6, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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 II
- Recalling firm
- BD KIESTRA LAB AUTOMATION
- Quantity
- 82 units (7 US, 65 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1658-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All; |
Match all identifying details in the current notice. A brand name alone is not enough.
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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 8, 2026
- Recall initiation date
- Feb 6, 2026
- Center classification date
- Mar 27, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.