Z-1658-2026Class II

BD Kiestra" ReadA; Catalog No.: 446948

Name: Z-1658-2026 BD Kiestra" ReadA; Catalog No.: 446948
Creator: Bd Kiestra Lab Automation
Published: 2026-02-06
License: https://open.fda.gov/license/

BD Kiestra B.V. / initiated 2026-02-06 / Open, Classified / root cause: software

FDA source

BD KIESTRA LAB AUTOMATION began a recall of BD Kiestra" ReadA; Catalog No.: 446948 on 2026-02-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1658-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-06
Posted: 2026-03-27
Recalling firm: BD Kiestra B.V.
Product: BD Kiestra" ReadA; Catalog No.: 446948.
Product code: JTQ Bath, Incubators/Water, All
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: 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)
Quantity in commerce: 82 units (7 US, 65 OUS)
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 codes and lots: Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1658-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1658-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27

Product code JTQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)