CLASS II Device recall · Reported 20 Sep 2017 · FDA Enforcement Report

Cell Marque, Glypican-3 (1G12 Mab) recalled by Leica Biosystems Richmond

Leica Biosystems Richmond is recalling Cell Marque, Glypican-3 (1G12 Mab), distributed nationwide in the US. The recall was initiated on 14 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code PA0800, Lot No. 46232, Exp. Date 06/04/2019

Quantity recalled3

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3121-2017
FDA event ID: 78055
Recalling firm: Leica Biosystems Richmond, Richmond, IL
Classification: Class II
Status: Terminated
Recall initiated: 14 Jul 2017
FDA classified: 12 Sep 2017
Reported: 20 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Temperature Abuse
Device type: Test Kits & Diagnostics

Timeline

14 Jul 2017	Recall initiated by company
12 Sep 2017	Classified by FDA	+60 days
20 Sep 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.

Where it was distributed

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.

Nationwide Arkansas Arizona California Connecticut Florida Georgia Illinois Indiana Kentucky Louisiana Michigan Minnesota North Carolina New Hampshire Nevada New York Oregon Pennsylvania South Carolina Tennessee

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Product Code PA0800, Lot No. 46232, Exp. Date 06/04/2019

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 78055

This product is part of a recall event; the main page for the event is Cell Marque, PAX8 (MRQ-50 Mab.) recalled by Leica Biosystems Richmond.

Reported	Class	Recall	Company	Reason	Where
20 Sep 2017	CLASS II	Cell Marque, PAX8 (MRQ-50 Mab.) recalled by Leica Biosystems Richmond	Leica Biosystems Richmond	Temperature Abuse	Nationwide
20 Sep 2017	CLASS II	Cell Marque, Podoplanin (D2-40 Mab) recalled	Leica Biosystems Richmond	Temperature Abuse	Nationwide
20 Sep 2017	CLASS II	Cell Marque, Napsin A (MRQ-60 Mab.) recalled	Leica Biosystems Richmond	Temperature Abuse	Nationwide
20 Sep 2017	CLASS II	Cell Marque, SOX-10 (Polyclonal) recalled by Leica Biosystems Richmond	Leica Biosystems Richmond	Temperature Abuse	Nationwide
20 Sep 2017	CLASS II	Cell Marque, MSH6 (44 Mab.) recalled by Leica Biosystems Richmond	Leica Biosystems Richmond	Temperature Abuse	Nationwide
20 Sep 2017	CLASS II	Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.) recalled	Leica Biosystems Richmond	Temperature Abuse	Nationwide

More recalls from Leica Biosystems Richmond

All 9

Reported	Class	Recall	Company	Reason	Where
20 Sep 2017Device	CLASS II	Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.) recalled	Leica Biosystems Richmond	Temperature Abuse	Nationwide
20 Sep 2017Device	CLASS II	Cell Marque, MSH6 (44 Mab.) recalled by Leica Biosystems Richmond	Leica Biosystems Richmond	Temperature Abuse	Nationwide
20 Sep 2017Device	CLASS II	Cell Marque, SOX-10 (Polyclonal) recalled by Leica Biosystems Richmond	Leica Biosystems Richmond	Temperature Abuse	Nationwide
20 Sep 2017Device	CLASS II	Cell Marque, Napsin A (MRQ-60 Mab.) recalled	Leica Biosystems Richmond	Temperature Abuse	Nationwide
20 Sep 2017Device	CLASS II	Cell Marque, Podoplanin (D2-40 Mab) recalled	Leica Biosystems Richmond	Temperature Abuse	Nationwide

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