The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-3121-2017·Announced 2017-09-20

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.

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: 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…
Manufacturer
Leica Biosystems Richmond Inc.
Category
Medical Device — In Vitro Diagnostic
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

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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 →

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