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U.S. Department of Health and Human Services

Class 2 Device Recall BD Kiestra"

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 Class 2 Device Recall BD Kiestra"see related information
Date Initiated by FirmFebruary 06, 2026
Date PostedMarch 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1658-2026
Recall Event ID 98473
Product Classification Bath, incubators/water, all - Product Code JTQ
ProductBD Kiestra" ReadA; Catalog No.: 446948.
Code Information Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
FEI Number 3010141591
Recalling Firm/
Manufacturer		 BD KIESTRA LAB AUTOMATION
Marconilaan 6
Drachten Netherlands
Manufacturer 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.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionOn 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)
Quantity in Commerce82 units (7 US, 65 OUS)
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;
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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