Leica Biosystems Cell Marque PAX8 Antibody Recall: Temperature Storage Risk
Leica Biosystems recalls PAX8 (MRQ-50) antibody products due to potential temperature storage issues affecting lab diagnostics. This may impact accuracy of IHC testing if stored outside recommended conditions.
Lower-risk recall
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Contact the company
What happened, in plain English
Leica Biosystems is recalling PAX8 (MRQ-50) antibody products that may have been stored outside recommended temperature ranges. This could affect the accuracy of immunohistochemistry tests if the product is used after improper storage. Read more at govinfonow.com/recall/73410-leica-biosystems-cell-marque-pax8-antibody-recall-temperature-storage-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73410-leica-biosystems-cell-marque-pax8-antibody-recall-temperature-storage-risk · Updated September 20, 2026 · FDA enforcement record: FDA #Z-3125-2017
Cite this page
“Leica Biosystems Cell Marque PAX8 Antibody Recall: Temperature Storage Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73410-leica-biosystems-cell-marque-pax8-antibody-recall-temperature-storage-risk. Based on FDA recall #Z-3125-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3125-2017%22&limit=1).
Why it’s dangerous
The product may have been stored outside the required temperature range during shipping, which could affect its stability. This might lead to inaccurate results in immunohistochemistry tests if the product is used after improper storage.
Who’s affected
Lab technicians and researchers using PAX8 antibody products for immunohistochemistry testing. Those who have the product with lot number 47795 or expired before September 24, 2019 are most at risk.
How to tell if you have this one
Check for the product code PA0808 and lot number 47795 on the packaging. The expiration date is September 24, 2019. This product is intended for laboratory use in IHC testing.
- Brand
Leica Biosystems- Category
Medical device
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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 number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3120-2017 | Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods; Product Code PA0796, Lot No. 47793, Exp. Date 09/24/2019 | 4 |
| Z-3121-2017 | 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.; Product Code PA0800, Lot No. 46232, Exp. Date 06/04/2019 | 3 |
| Z-3122-2017 | Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.; Product Code PA0803, Lot No. 46524, Exp. Date 06/25/2019 | 10 |
| Z-3123-2017 | Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).; Product Code PA0804, Lot No. 45973, Exp. Date 05/21/2019 | 13 |
| Z-3124-2017 | Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.; Product Code PA0805, Lot No. 46349, Exp. Date 06/11/2019 | 33 |
| Z-3125-2017 | Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing; Product Code PA0808, Lot No. 47795, Exp. Date 09/24/2019 | 5 |
| Z-3126-2017 | 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 Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing..; Product Code PA0813, Lot No. 47800, Exp. Date 09/24/2019 | 37 |
What to do — step by step
Check Product Details
Verify the product code (PA0808) and lot number (47795) on the packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 23 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Nevada, New Hampshire, New York, North Carolina, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 7.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3125-2017 (July 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3125-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.