CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report

Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) recalled

Foundation Medicine is recalling Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx), distributed nationwide in the US. The recall was initiated on 20 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.

Quantity recalled163 units

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-1927-2026
FDA event ID: 98625
Recalling firm: Foundation Medicine, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 20 Mar 2026
FDA classified: 22 Apr 2026
Reported: 29 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Mar 2026	Recall initiated by company
22 Apr 2026	Classified by FDA	+33 days
29 Apr 2026	Published in enforcement report	+7 days

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

Reason for recall

Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants

Product as listed by the FDA

Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Where it was distributed

US Nationwide distribution in the states of Massachusetts and North Carolina.

Nationwide Massachusetts North Carolina

Questions about this recall

Is Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) recalled?

Yes. Foundation Medicine recalled Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) on 20 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1927-2026.

Why was it recalled?

Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants

Which lots are affected?

Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.

Where was it sold?

US Nationwide distribution in the states of Massachusetts and North Carolina.

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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26 Aug 2026Device	CLASS II	Hamilton Microlab STAR Liquid Handler recalled by Foundation Medicine	Foundation Medicine	Device Malfunction	Nationwide
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11 Jun 2025Device	CLASS II	FoundationOne Companion Diagnostic (F1CDx) recalled	Foundation Medicine	Other	Nationwide

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