Leica Biosystems Recalls Podoplanin Antibody Due to Temperature Excursion
Leica Biosystems Richmond Inc. is recalling four units of Podoplanin (D2-40 Mab) antibody because a delay in transit may have caused the product to be stored outside of 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential loss of product efficacy due to temperature excursion, which fits the criteria for a moderate severity score.
Plain-English summary
Leica Biosystems Richmond Inc. is recalling four units of Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, an in vitro diagnostic (IVD) antibody. The product is intended for qualified laboratories to qualitatively identify associated antigens in tissue sections using immunohistochemistry (IHC) test methods.
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 specific lot number is 47793, with an expiration date of 09/24/2019.
The affected units were 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 product and contact the manufacturer for further instructions.
The recalled product
- Product
- 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 s
- Manufacturer
- Leica Biosystems Richmond Inc.
- Affected units
- 4
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 PA0796
- Lot No. 47793
- 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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