Medical device recalls

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

Recall date
March 15, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1202-2019
FDA classification
Class III
Brand / firm
Cytocell Ltd.
Sold / distributed
The products were distributed to the following US states: IL, TN.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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