Diagnostics Firm Warned for Product Mix-Ups

Louisville APL Diagnostics failed to consult the FDA about several product recalls, according to a warning letter posted to the agency’s website last week. Therefore, its diagnostic kits are adulterated and do not conform with current good manufacturing practice requirements, the letter said.

The firm manufactures semiquantitative enzyme-linked immunosorbent assay kits to aid in the diagnosis of Antiphospholipid Syndrome in patients with thrombosis and/or thrombocytopenia.

The company was cited after failing to identify a value error in the positive control range on the quality control fact sheet for a batch of single test kits. The fact sheet for the double test kits also had the same error, the letter said. The firm subsequently received a customer complaint of aberrant laboratory test results, instructed the customer to discard the incorrect fact sheets and sent them the correct fact sheets, the letter said.

Louisville APL Diagnostics could not be reached for comment by press time.

The warning letter can be seen at www.fda.gov/foi/warning_letters/s6464c.pdf.