FDA Medical Device Recalls (openFDA)
Cytocell Ltd.: Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
- Recall number
- Z-1493-2021
- Recalling firm
- Cytocell Ltd.
- Product
- Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
- Status
- Open, Classified
- Initiated
- 2021-03-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
- 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
- 89 probes
- Distribution
- US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.
- Lot, serial or model codes
- Lot: RD20/253/16, RD21/043/01, RD21/043/02
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 3002646096
- Firm city
- Cambridge
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28