Z-1493-2021Class II

Chromosome X Alpha-Satellite in FITC Spectrum -

Name: Z-1493-2021 Chromosome X Alpha-Satellite in FITC Spectrum -
Creator: Cytocell Ltd.
Published: 2021-03-19
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2021-03-19 / Open, Classified

FDA source

Cytocell Ltd. began a recall of Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481 on 2021-03-19. FDA classified it as Class II and gives the reason as "Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1493-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-19
Posted: 2021-04-26
Recalling firm: Cytocell Limited
Product: Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Product code: MVU Reagents, Specific, Analyte
Reason for recall: Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
FDA root cause: Under Investigation by firm
Action: On 3/19/2021, Cytocell issued an Urgent Medical Device Recall notice via email notifying customers they may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
Quantity in commerce: 89 probes
Distribution: US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.
Product codes and lots: Lot: RD20/253/16, RD21/043/01, RD21/043/02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1493-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1493-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-05	2021-04-26

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)