FDA reprimands test makers over improper severity ratings, marketing unauthorized diagnostic

The US Food and Drug Administration (FDA) has recently warned two test makers: one for failing to assign appropriate severity ratings for a blood test used to screen for various diseases and another sent to a firm for not seeking approval of device used to screen for colorectal cancer.

Beckman Coulter

FDA sent a warning letter on 15 March to Beckman Coulter for several violations of Good Manufacturing Practices (GMPs) involving its DxI 9000 Access Immunoassay analyzer at the firm’s site in Chaska, MN, following a six-week period starting in November 2023. These analyzers are used in clinical laboratories and hospitals to determine protein, bacterial or viral toxins, to detect infectious diseases, and to measure cardiac markers.

One of the problems found by investigators was the firm assigned an incorrect severity rating for the product’s failure modes. FDA said that the firm’s immunoassay instruments Product Safety Reference (PSR) false/high positive reported failure mode was “inappropriately” placed in a low-risk category.

FDA said that “risks associated with false negative HBs Ag, HBc IgM, and HBc Ab may be more clinically serious and include missed diagnosis of acute HBV infection (HBc IgM and HBc Total) and chronic HBV infection (HBs Ag).”

FDA further notes that “from a public health standpoint, a false negative result on any of these assays also leads to increased risk of HBV transmission to others. Because the risk of false negatives in these assays include [redacted] to the patient and others, your firm’s Severity Rating for the HBc IgM is determined to be incorrectly evaluated as [redacted].”

The warning letter also raised issues with the company’s corrective and preventative action (CAPA) procedures related to nonconforming products, as well as its procedures for controlling nonconforming products.

The agency gave the company 15 days to respond to the warning letter and identify any corrective actions they are taking to address the issues.

Agena Bioscience

FDA also issued a warning letter to San Diego-based Agena Bioscience for lacking proper marketing authorization for its iPLEX HS Colon Panel, which is intended for use with the firm’s MassARRAY4 System (MA4) system. While the firm labeled the iPLEX HS Colon Panel “For Research Use Only,” FDA said it appeared that the company was marketing the test for clinical diagnostic use.

FDA said that distribution records and a customer list showed that the firm shipped MA4 Systems and iPLEX HS Colon Panels to clinical testing laboratories. A customer notification sent to a customer in June 2021 “alerted customers of an increase in false negative results of certain reagent lots and stated that Agena was taking steps” to address this issue. The notification was sent to a clinical hospital in Texas “and there is no evidence that these reagents were intended for research use only.

Further, the company’s website asserted that the iPLEX HS Colon Panel “enables tumor profiling studies of colorectal cancer specimens” and that “users can ‘Detect more than 80 clinically relevant variants across BRAF, EGFR, KRAS, NRAS, and PIK3CA’ and ‘Identify variants at as low as 1% variant allele frequency.’”

FDA said that “your iPLEX HS Colon Panel intended for use with the MA4 appears to be a tumor profiling test intended for the diagnosis of colorectal cancer. You were required to submit to FDA a 510(k) for this device, because it either is a new device (21 CFR 807.81(a)(1)) or, if your iPLEX HS Colon Panel intended for use with the MA4 represents a change or modification from the device cleared in K132978 (which is indicated for use as an aid in diagnosis of patients with suspected thrombophilia), has been significantly changed or modified in design, components, method of manufacture, or intended use (21 CFR 807.81(a)(3)).”

The firm has 15 days to respond to the warning letter and list the steps they are taking to address the citations.

Beckman Coulter, Agena Bioscience

FDA reprimands test makers over improper severity ratings, marketing unauthorized diagnostic

Related topics

Recommended content

Welcome to the new RAPS Digital Experience