FDAClass IISeptember 20, 2017

Cell Marque recall

Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary…

Why was Cell Marque recalled?

A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.

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?

Product Code PA0813, Lot No. 47800, Exp. Date 09/24/2019

Product
Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary…
Recalling firm
Leica Biosystems Richmond Inc.
Quantity
37
Distribution
Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
Recall date
September 20, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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