Summary
The FDA issued a Class II for BD Kiestra" ReadA; Catalog No.: 446948. by BD KIESTRA LAB AUTOMATION. Reason: In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occ.
Details
Source
Device Recall
External ID
Z-1658-2026
Action Date
2026-04-08
Status
Ongoing
Category
device
Product Description
BD Kiestra" ReadA; Catalog No.: 446948.
Lot/Code Info: Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
Quantity Affected: 82 units (7 US, 65 OUS)
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;
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-06
Company
Drachten
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BD KIESTRA LAB AUTOMATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BD KIESTRA LAB AUTOMATION have FDA actions?
This is the only FDA action we have on record for BD KIESTRA LAB AUTOMATION in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1658-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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