Cytocell recalls

Cytocell has 14 recalls on record with the FDA and USDA, the earliest in 2019 and the latest reported on 26 Jul 2023. 3 are still ongoing.

Total recalls14since 2019

Last 12 months0reported

Class I00% of total

Ongoing3latest 26 Jul 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 10 71%Class III 4 29%

Why cytocell is recalled

Product types

Other Medical Devices750%
Test Kits & Diagnostics750%

By year

2023214%
2022536%
2021429%
202017%
2019214%

Ongoing cytocell recalls

3 active

Reported	Class	Recall	Company	Reason	Where
26 Jul 2023Device	CLASS II	RET Proximal Probe recalled by Cytocell	Cytocell	Other	Nationwide
26 Jul 2023Device	CLASS II	RET Distal Probe recalled by Cytocell	Cytocell	Other	Nationwide
5 May 2021Device	CLASS II	Chromosome X Alpha-Satellite in FITC Spectrum recalled by Cytocell	Cytocell	Other	Nationwide

All cytocell recalls, newest first

14 total

Reported	Class	Recall	Company	Reason	Where
26 Jul 2023Device	CLASS II	RET Proximal Probe recalled by Cytocell	Cytocell	Other	Nationwide
26 Jul 2023Device	CLASS II	RET Distal Probe recalled by Cytocell	Cytocell	Other	Nationwide
7 Dec 2022Device	CLASS II	BCL11B Proximal in FITC Spectrum-LDT recalled by Cytocell	Cytocell	Labeling Errors	TX
7 Dec 2022Device	CLASS II	BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent recalled	Cytocell	Packaging Defects	TX
30 Mar 2022Device	CLASS III	TCL1 Breakapart Probe, Fluorescence in situ hybridisation recalled	Cytocell	Device Malfunction	MN
30 Mar 2022Device	CLASS III	8 Square Template Slides (Glass)- microscope slides recalled by Cytocell	Cytocell	Foreign Material	Nationwide
16 Mar 2022Device	CLASS II	Del(5q) Deletion FISH Probe Kit recalled by Cytocell	Cytocell	Other	Nationwide
25 Aug 2021Device	CLASS II	LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic recalled	Cytocell	Device Malfunction	Nationwide
4 Aug 2021Device	CLASS II	DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe recalled	Cytocell	Other	7 states
5 May 2021Device	CLASS II	Chromosome X Alpha-Satellite in FITC Spectrum recalled by Cytocell	Cytocell	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.