Leica Biosystems Recalls PAX8 Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling five units of PAX8 antibody because a transit delay may have caused the product to be stored outside required temperature limits.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard involves potential product nonconformity due to temperature deviation, which is a quality control issue rather than a direct, reported physical injury or high-risk pathogen exposure.
Plain-English summary
Leica Biosystems Richmond Inc. is recalling five units of Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD. This product is a mouse monoclonal primary antibody intended for in vitro diagnostic (IVD) use in laboratory testing to detect the PAX-8 protein in formalin-fixed, paraffin-embedded tissue.
The recall was initiated because a delay in transit may have contributed to nonconformity, as the product was stored outside of defined shipping and handling temperature requirements. The affected units are identified by Product Code PA0808, Lot No. 47795, and an expiration date of 09/24/2019.
The product was distributed nationwide to laboratories in Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Wisconsin. Users should stop using the affected product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 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 s
- Manufacturer
- Leica Biosystems Richmond Inc.
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Code PA0808
- Lot No. 47795
- Exp. Date 09/24/2019
Distribution
Part of a larger recall action
This product is one of 7 recalled by Leica Biosystems Richmond Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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