Leica Biosystems Recalls SOX-10 Antibody Due to Temperature Excursion
Leica Biosystems Richmond Inc. is recalling 37 units of SOX-10 (Polyclonal) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a Class II recall involving a potential temperature excursion that may affect product performance, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Leica Biosystems Richmond Inc. is recalling 37 units of Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD. This product is an antibody intended for in vitro diagnostic (IVD) use in laboratory testing for the detection of the SOX-10 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 product code is PA0813, Lot No. 47800, with an expiration date of 09/24/2019.
The product was distributed nationwide 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. Users should stop using the affected product and contact the recalling firm for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Leica Biosystems Richmond Inc.
- Affected units
- 37
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 PA0813
- Lot No. 47800
- 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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