Leica Biosystems Recalls MiTF Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling 10 units of Microphthalmia Transcription Factor (MiTF) antibody because a transit delay caused the product to be stored outside required temperature ranges.
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, and the source text indicates a potential nonconformity due to temperature deviation without reporting of specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Leica Biosystems Richmond Inc. is recalling 10 units of Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803. This in vitro diagnostic (IVD) antibody 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 affected product is identified by Product Code PA0803, Lot No. 46524, and an expiration date of 06/25/2019.
The product was distributed nationwide to laboratories in AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI. Users should stop using the affected product and contact Leica Biosystems Richmond Inc. for further instructions.
The recalled product
- Product
- 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 ident
- Manufacturer
- Leica Biosystems Richmond Inc.
- Affected units
- 10
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 PA0803
- Lot No. 46524
- Exp. Date 06/25/2019
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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