BD Kiestra" ReadA recallZ-1658-2026 · Bd Kiestra Lab Automation · initiated Feb 6, 2026
Class II Open, Classified All recalls posted in March 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bd Kiestra Lab Automation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
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 your receipt of this notification per FDA requirements. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088)
Recall details
- Recall number
- Z-1658-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Feb 6, 2026
- Posted by the FDA
- Mar 27, 2026
- Recalling firm
- Bd Kiestra Lab Automation
- Quantity
- 82 units (7 US, 65 OUS)
- Product code
- JTQ
- 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;
Product description
BD Kiestra" ReadA; Catalog No.: 446948.
Code information (models, lots, serial numbers)
Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Kiestra™ ReadA 446948BD Kiestra B.V. · BATH, INCUBATORS/WATER, ALL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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