Johnson and Johnson company recalls major disease screening reagent

The Johnson & Johnson subsidiary Ortho-Clinical Diagnostics has announced a recall of a reagent used in a lab test system as it can provide inaccurate results.

Test results using the reagent may results in incorrect results for tests involving areas such as cardiac, hepatitis A, B and C, thyroid disorders, HIV and pregnancy, according to the company.

Used in conjunction with the Vitros Immunodiagnostic ECi/ECiQ laboratory test system, the reagent is part of a process for the laboratory screening for in excess of 40 diseases including the above-mentioned.

Ortho-Clinical Diagnostics has said that of the 50 lots of the reagent currently in distribution worldwide, four per cent (two lots) are affected by the recall, one that has been distributed in the US and one that has been distributed elsewhere.

The Johnson & Johnson company has urged any laboratory that has used the reagent to contact patient’s physicians if they have concerns over screening results produced for such conditions as HIV, pregnancy or heart attacks, among others.

It has also suggested that patients tested for any conditions in the last 60 days using the technology contact their doctor if unsure over the results.

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