Food, drugs, devices › Leica Biosystems Richmond Inc.
Device recall: Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use.
Leica Biosystems Richmond Inc. (Richmond, IL) initiated this device recall on 14 Jul 2017; FDA lists 7 product records under event 78055, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 2 Aug 2024. Initiation: voluntary: firm initiated. Leica Biosystems Richmond Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Leica Biosystems Richmond Inc., Richmond, IL.
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."
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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,… | 4 | Class II | Terminated | 20 Sep 2017 |
| 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… | 3 | Class II | Terminated | 20 Sep 2017 |
| 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… | 10 | Class II | Terminated | 20 Sep 2017 |
| 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… | 13 | Class II | Terminated | 20 Sep 2017 |
| 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… | 33 | Class II | Terminated | 20 Sep 2017 |
| 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… | 5 | Class II | Terminated | 20 Sep 2017 |
| 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… | 37 | Class II | Terminated | 20 Sep 2017 |
Context
Other enforcement events for Leica Biosystems Richmond Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 May 2016 | Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an ai | Device | Class III | 1 |
| 2 May 2016 | CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase fin | Device | Class III | 1 |
All 3 events for Leica Biosystems Richmond Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Aug 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.