Leica Biosystems Recalls Glypican-3 Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling three units of Glypican-3 (1G12 Mab) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.
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 specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Leica Biosystems Richmond Inc. is recalling three units of Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD. The product is an in vitro diagnostic antibody intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.
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 46232, with an expiration date of 06/04/2019.
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 recalling firm for further instructions.
The recalled product
- Product
- Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedde
- Manufacturer
- Leica Biosystems Richmond Inc.
- Hazard
- Affected units
- 3
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 PA0800
- Lot No. 46232
- Exp. Date 06/04/2019
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.
See all 7 products in this recall →Related recalls
Same manufacturer · Leica Biosystems Richmond Inc.
See all →- ModerateLeica Biosystems Recalls Podoplanin Antibody Due to Temperature Excursion
FDA (Devices) · 2017-09-20
- ModerateLeica Biosystems Recalls MSH6 Antibody Due to Temperature Deviation
FDA (Devices) · 2017-09-20
- ModerateLeica Biosystems Recalls Napsin A Antibody Due to Temperature Excursion
FDA (Devices) · 2017-09-20
- ModerateLeica Biosystems Recalls MiTF Antibody Due to Temperature Deviation
FDA (Devices) · 2017-09-20
- ModerateLeica Biosystems Recalls SOX-10 Antibody Due to Temperature Excursion
FDA (Devices) · 2017-09-20
Same hazard · temperature deviation
See all →- ModerateCitalopram Tablets Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- HighDonepezil Hydrochloride Tablets Recalled Due to Storage Temperature Deviations
FDA (Drugs) · 2024-01-03
- ModerateLeader Nasal Decongestant PE recalled due to improper storage conditions
FDA (Drugs) · 2024-01-03
- ModerateAmoxicillin oral suspension recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03
- HighLow-dose aspirin recall due to improper storage temperature conditions
FDA (Drugs) · 2024-01-03