FDA Device recall Z-1202-2019
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent
- FDA Device
- Class III
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class III recall of Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent by Cytocell, citing there is an error in the chromomap included in the labeling for the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1202-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-03-15 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cytocell |
| Distribution | IL, TN |
Product
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Reason
There is an error in the chromomap included in the labeling for the product.
Identifiers
| code_info | Lot numbers: 056996 061156 062616 062808 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1202-2019%22
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