FDA recall Z-1202-2019
Cytocell Ltd. · Class III · device
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.
Distribution
The products were distributed to the following US states: IL, TN.
Key facts
- Status
- Terminated
- Initiation date
- 2019-03-15
- Report date
- 2019-05-01
- Termination date
- 2020-10-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Adderbury Banbury Oxfordshire, N/A, United Kingdom
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2019