Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0739-2020·Announced 2020-01-01

Ortho Clinical Diagnostics Recalls VITROS 7% BSA Diluent Due to Instability

Ortho Clinical Diagnostics is recalling VITROS 7% BSA diluent because it may become unstable when stored in a 2mL cup for seven days.

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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential instability issue rather than a direct safety threat like fire or toxic contamination, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Ortho Clinical Diagnostics Inc is recalling VITROS 7% BSA (Bovine Serum Albumin), Product Code 8262487. The product is used to dilute samples when assay values exceed the reportable range on specific VITROS Chemistry and Integrated Systems. The recall involves 16,584 units distributed worldwide, including the United States and various international markets.

The recall is being issued due to a potential for instability of the diluent when stored in a 2mL cup for seven days. This issue may affect the reliability of the product during its intended use in laboratory settings. The source text does not report any specific illnesses, injuries, or adverse health consequences associated with this recall.

Healthcare facilities and laboratories should stop using the affected lots and contact Ortho Clinical Diagnostics for further instructions. The affected lots include D6289, E6382, F6602, G6679, H6897, J7129, K7421, and L7592, with expiry dates ranging from 2019 to 2021.

The recalled product

Product: 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
Manufacturer: Ortho Clinical Diagnostics Inc
Category: Medical Device — Laboratory Reagent
Hazard: instability
product-defect
Affected units: 16,584

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Ortho Clinical Diagnostics 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 2 products in this recall →

Same manufacturer · Ortho Clinical Diagnostics Inc

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