CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report

BD Kiestra" ReadA recalled

Bd Kiestra Lab Automation is recalling BD Kiestra" ReadA, distributed nationwide in the US. The recall was initiated on 6 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;

Quantity recalled82 units (7 US, 65 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1658-2026
FDA event ID: 98473
Recalling firm: Bd Kiestra Lab Automation, Drachten
Classification: Class II
Status: Ongoing
Recall initiated: 6 Feb 2026
FDA classified: 27 Mar 2026
Reported: 8 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

6 Feb 2026	Recall initiated by company
27 Mar 2026	Classified by FDA	+49 days
8 Apr 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

BD Kiestra" ReadA; Catalog No.: 446948.

Where it was distributed

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;

Nationwide Kansas Maryland Minnesota New Jersey Texas Virginia

Questions about this recall

Is BD Kiestra" ReadA recalled?

Yes. Bd Kiestra Lab Automation recalled BD Kiestra" ReadA on 6 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-1658-2026.

Why was it recalled?

Which lots are affected?

Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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