Leica Biosystems Recalls MSH6 Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling 13 units of MSH6 antibody (REF PA0804) because a delay in transit may have caused the product to be stored outside of 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential loss of product efficacy due to temperature deviation, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Leica Biosystems Richmond Inc. is recalling 13 units of Cell Marque MSH6 (44 Mab.) antibody, product code PA0804, lot number 45973, with an expiration date of 05/21/2019. The product is an in vitro diagnostic (IVD) reagent intended for use in testing for microsatellite instability (MSI-H), a condition associated with Hereditary Non-Polyposis Colon Cancer (HNPCC).
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 agency has classified this as a Class II recall.
The affected units were 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 product and contact the manufacturer for further instructions.
The recalled product
- Product
- 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 autoso
- Manufacturer
- Leica Biosystems Richmond Inc.
- Affected units
- 13
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 PA0804
- Lot No. 45973
- Exp. Date 05/21/2019
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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