Cytocell Ltd.: Medical Device Recall in 2021 - (Recall #: Z-1493-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481

Product Classification:

Class II

Date Initiated: March 19, 2021

Date Posted: May 5, 2021

Recall Number: Z-1493-2021

Event ID: 87621

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.

Status: Ongoing

Product Quantity: 89 probes

Code Information:

Lot: RD20/253/16, RD21/043/01, RD21/043/02

Distribution Pattern:

US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.

Voluntary or Mandated:

Voluntary: Firm initiated