The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-3124-2017·Announced 2017-09-20

Leica Biosystems Recalls Napsin A Antibody Due to Temperature Excursion

Leica Biosystems Richmond Inc. is recalling 33 units of Napsin A (MRQ-60 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, which corresponds to a moderate severity score. The hazard involves a potential temperature excursion that may have compromised product integrity, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Leica Biosystems Richmond Inc. is recalling 33 units of Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD. The product is a mouse monoclonal primary antibody intended for in vitro diagnostic (IVD) use in laboratory testing to detect the Napsin A 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 is identified by Product Code PA0805, Lot No. 46349, and an expiration date of 06/11/2019.

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, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed…
Manufacturer
Leica Biosystems Richmond Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
33

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 PA0805
  • Lot No. 46349
  • Exp. Date 06/11/2019

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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