FDAClass IIIMay 1, 2019

Aquarius CSF1R/RPS14 recall: Labeling Error

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

Why was Aquarius CSF1R/RPS14 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: 056996 061156 062616 062808

Product
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Recalling firm
Cytocell Ltd.
Quantity
19
Distribution
The products were distributed to the following US states: IL, TN.
Recall date
May 1, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls