FDA-Device2019-05-01Class III

Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

Cytocell Ltd.
Hazard

There is an error in the chromomap included in the labeling for the product.

Sold states
The products were distributed to the following US states: IL, TN.
Affected count
19
Manufactured in
Somerville Court, Unit 8, Banbury Business Park, Adderbury Banbury Oxfordshire, N/A, United Kingdom
Products
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2019

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