# FDA recall Z-1658-2026

> **BD KIESTRA LAB AUTOMATION** · Class II · device recall initiated 2026-02-06.

## Product

BD Kiestra" ReadA;  Catalog No.: 446948.

## 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.

## 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;

## Key facts

- **Recall number:** Z-1658-2026
- **Recalling firm:** BD KIESTRA LAB AUTOMATION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-06
- **Report date:** 2026-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Drachten, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1658-2026

## Citation

> AI Analytics. FDA recall Z-1658-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1658-2026. Source: US FDA. Licensed CC0.

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