Chromosome X Alpha-Satellite in FITC Spectrum — Class II medical device recall Z-1493-2021
Ongoing recall by Cytocell Ltd., reported 2021-05-05, distributed nationwide. Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no
| Recall number | Z-1493-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Cambridge, N/A, United Kingdom |
| Recall initiated | 2021-03-19 |
| Classified | 2021-04-26 |
| Reported by FDA | 2021-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 89 probes |
| Lot numbers | RD20/253/16, RD21/043/01, RD21/043/02 |
| Model numbers | MPA3481 |
Product
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1493-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.