Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1069-2017·Announced 2017-02-01

Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results

The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield falsely low results for samples with extremely high IgG4 levels.

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 typically corresponds to a Moderate severity score when the hazard involves diagnostic inaccuracy rather than direct physical injury or death.

Plain-English summary

The Binding Site Group, Ltd. is recalling Human IgG4 Subclass Liquid Reagent Kits (Product Code LK009.CB) for use on the Roche Cobas 6000 and Beckman Coulter AU series analyzers. The recall was initiated after customer complaints identified that the kits may produce spuriously low IgG4 results when analyzing samples containing extremely high levels of the antibody due to antigen excess.

The recall includes all lots of the product. The kits were distributed worldwide, including in the United States (Florida, Ohio, Tennessee, Minnesota, New York, Michigan, and California) and internationally to countries such as Canada, France, the UK, and Germany. These kits are intended for the quantitative measurement of human IgG subclasses 1, 2, 3, and 4 in serum for the diagnosis of abnormal protein metabolism and immune system deficiencies.

Healthcare facilities and laboratories should stop using the affected reagent kits and contact The Binding Site Group, Ltd. for instructions on returning the product or obtaining a replacement. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal…
Manufacturer: The Binding Site Group, Ltd.
Category: Medical Device — Laboratory Reagents
Hazard: mis-labeling

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 (1)

All lots.

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 7 recalled by The Binding Site Group, Ltd. 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 →

Same manufacturer · The Binding Site Group, Ltd.

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