The Recall Desk
LowFDA (Devices)·Z-1202-2019·Announced 2019-05-01

Cytocell Recalls Aquarius CSF1R/RPS14 Probe Due to Labeling Error

Cytocell Ltd. is recalling 19 units of the Aquarius CSF1R/RPS14 Probe Red due to an error in the chromomap labeling.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Cytocell Ltd. is recalling 19 units of the Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent. The recall is being conducted because there is an error in the chromomap included in the product labeling.

The affected products were distributed to the states of Illinois and Tennessee. The specific lot numbers involved in this recall are 056996, 061156, 062616, and 062808.

This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Users should stop using the product and contact the manufacturer for further instructions.

The recalled product

Product
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Manufacturer
Cytocell Ltd.
Affected units
19

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot numbers: 056996 061156 062616 062808

Distribution

Distributed in 2 states: