Quick Facts at a Glance
- Recall Date
- February 6, 2026
- Hazard Level
- HIGH
- Brand
- BD Kiestra Lab Automation
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 6 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BD Kiestra Lab Automation
- Product type
- Laboratory automation module
- Model numbers
- 446948, 00382904469481
- Sold at
- Multiple Retailers
- Where affected
- KS, MD, MN, NJ, TX, VA
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 6, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BD KIESTRA LAB AUTOMATION or your healthcare provider for instructions. Notification method: Letter
About This Product
BD Kiestra ReadA is part of the BD Kiestra Lab Automation system used in clinical microbiology labs to automate plate incubation and processing.
Why This Is Dangerous
An intermittent connectivity issue after reboot can render modules unreachable via the remote interface, causing delays in plate retrieval from the incubator. The issue has not affected test results, assay performance, or sample integrity.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Delays in plate retrieval may affect workflow and turnaround times in busy labs. There is no reported impact on test accuracy or sample integrity.
Practical Guidance
How to identify if yours is affected
- Check Catalog No. 446948 on the device label.
- Confirm Serial Numbers: All.
- Review recall notice and determine if the unit matches the affected characteristics.
Where to find product info
On the device label, recall notification, and FDA recall page linked to the notice.
What timeline to expect
Not specified by the manufacturer.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Document all interactions with the vendor
- Consider regulatory reporting if delays impact patient safety
How to prevent similar issues
- Ensure software updates and connectivity integrity for lab automation modules
- Develop backup workflows for plate retrieval during outages
- Verify device compatibility before integrating new modules
Documentation advice
Keep the recall notification, device identifiers, distribution records, and all correspondence with the manufacturer for audit trails.
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Product Details
Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All; Quantity: 82 units (7 US, 65 OUS); Domestic distribution: KS, MD, MN, NJ, TX, VA; International distribution: Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Kuwait, Mexico, Morocco, Netherlands, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom; Recall date: 2026-02-06; Company: BD Kiestra Lab Automation; Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 82 units recalled (7 US, 65 OUS)
- Serial Numbers: All
- Domestic distribution: KS, MD, MN, NJ, TX, VA
- International distribution: Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, HK
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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