FDA Device recall Z-1493-2021
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents
- FDA Device
- Class II
- ongoing
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents by Cytocell, citing users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1493-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-19 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cytocell |
| Distribution | US |
Product
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Reason
Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
Identifiers
| code_info | Lot: RD20/253/16, RD21/043/01, RD21/043/02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1493-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.