Diagnostics Firm Warned for Product Mix-Ups

Louisville APL Diagnostics failed to consult the FDA about several product recalls, according to a recent warning letter. 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 lot of single test kits.

The fact sheet for the double test kits 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 also failed to adequately inspect the labels of the test kit components before proceeding to the next step of manufacturing operations, according to the letter, which said IgG and IgM conjugates were switched during manufacturing — the IgG conjugate was placed in bottles labeled for the IgM conjugate and vice versa.

As a result, the company received a customer complaint of aberrant laboratory test results in one lot for the IgG Test Kits and later sent the replacement conjugates to the customer, instructing it to discard the mislabeled conjugates, the letter said.

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