CLASS III Device recall · Reported 30 Mar 2022 · FDA Enforcement Report

TCL1 Breakapart Probe, Fluorescence in situ hybridisation recalled

Cytocell is recalling TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows, distributed in Minnesota. The recall was initiated on 4 Feb 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot 074612

Quantity recalled1 unit

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-0814-2022
FDA event ID: 89669
Recalling firm: Cytocell, Cambridge, N/A
Classification: Class III
Status: Terminated
Recall initiated: 4 Feb 2022
FDA classified: 21 Mar 2022
Reported: 30 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

4 Feb 2022	Recall initiated by company
21 Mar 2022	Classified by FDA	+45 days
30 Mar 2022	Published in enforcement report	+9 days

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

Reason for recall

May show unexpected locus specific signals in addition to those at 14q32.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

Where it was distributed

Minnesota

Questions about this recall

Why was it recalled?

May show unexpected locus specific signals in addition to those at 14q32.

Which lots are affected?

Lot 074612

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 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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