FDAClass IIJuly 26, 2023

RET Proximal Probe. Used in Fluorescence in situ recall

RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a…

Why was RET Proximal Probe. Used in Fluorescence in situ recalled?

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Catalog No. LPS508-A; UDI-DI: 05055844900509; Lot No. 076763, 077253, 080125, 080763, 082128, 083041, 083246, 083555.

Product
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a…
Recalling firm
Cytocell Ltd.
Quantity
60 units
Distribution
US Nationwide distribution in the states of CA, FL, OH, & SC.
Recall date
July 26, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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