Aquarius CSF1R/RPS14 — Class III medical device recall Z-1202-2019
Terminated recall by Cytocell Ltd., reported 2019-05-01, distributed in IL, TN. There is an error in the chromomap included in the labeling for the product.
| Recall number | Z-1202-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Adderbury Banbury Oxfordshire, N/A, United Kingdom |
| Recall initiated | 2019-03-15 |
| Classified | 2019-04-19 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2020-10-13 |
| Distributed | IL, TN |
| Quantity | 19 |
| Reason classes | labeling |
| Lot numbers | 056996, 061156, 062616, 062808 |
| Model numbers | LPH540-A |
Product
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Reason for recall
There is an error in the chromomap included in the labeling for the product.
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-1202-2019. 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.