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