FDAClass IIAugust 25, 2021

Cytocell LPH019-A E2A recall

Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

Why was Cytocell LPH019-A E2A recalled?

May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34

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?

Lots 073004 and 072518 (Probe lot 200918-006).

Product
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Recalling firm
Cytocell Ltd.
Quantity
23 units
Distribution
US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
Recall date
August 25, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls