CLASS II Device recall · Reported 7 Dec 2022 · FDA Enforcement Report

BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent recalled

Cytocell is recalling CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent, distributed in Texas. The recall was initiated on 27 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: RD22/230/11

Quantity recalled3 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-0341-2023
FDA event ID: 91119
Recalling firm: Cytocell, Cambridge
Classification: Class II
Status: Terminated
Recall initiated: 27 Oct 2022
FDA classified: 30 Nov 2022
Reported: 7 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

27 Oct 2022	Recall initiated by company
30 Nov 2022	Classified by FDA	+34 days
7 Dec 2022	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

An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

Where it was distributed

Texas

Questions about this recall

Is BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent recalled?

Yes. Cytocell recalled BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent on 27 Oct 2022. The recall is Class II and its status is Terminated. Recall number Z-0341-2023.

Why was it recalled?

Which lots are affected?

Lot Number: RD22/230/11

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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