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FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months

by | May 27, 2024 | Compliance-lca, Essential, FDA-lir, Lab Industry Advisor

Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests

The U.S. Food and Drug Administration (FDA) has been busy in recent weeks scrutinizing laboratory operations, having issued warning letters to four different laboratory companies and lab equipment manufacturers about issues with marketing or quality.

Most warning letters from the FDA these days focus around the mismarketing or distribution of vaping devices and related products, as well as food products. Although warning letters to companies in the lab sector are issued, that three were sent out in a 33-day period in March and April is unusual. Most recently, a fourth warning letter was sent to Cue Health in May regarding the company’s COVID-19 tests.

According to data from the FDA, the number of Form 483 observations issued to medical device manufacturers—a category that includes laboratory companies—reached 720 in fiscal year (FY) 2023, up from 538 in FY 2022 and 191 in FY 2021. Warning letters are issued to companies if they fail to properly address the “objectionable” conditions noted by FDA inspectors in Form 483s.1

The warning letters

The most serious warning was issued to Beckman Coulter on March 15. The company was accused of slipshod quality processes in the manufacture of its DxI 9000 Access Immunoassay analyzer instrument system and related tests. The letter alleged that Beckman Coulter failed to adequately establish and maintain procedures for risk analysis for the platform, downplayed the risk of false results for testing for the hepatitis B surface antigen and other assays, and was not fully transparent on the risk of failure of the platform due to shortened tubing in some devices.2

“Your firm’s CAPA [corrective and preventative action] procedure and related standard operating procedures have not been adequately established to analyze quality data to identify existing and potential causes of nonconforming product or other quality problems,” the letter stated.2

The FDA also raised concerns that Beckman Coulter was not adequately establishing procedures to clearly verify the effectiveness and safety of design changes in the platform.

Two of the other warning letters, to San Diego, California-based Agena Bioscience and Nashville, Tennessee-based Pinnacle BioLabs, involve marketing issues.

The Agena letter, issued on March 21, focused on issues with the way the company was marketing its MassARRAY4 System and iPLEX HS chemistry panel, which includes an assay for determining genetic variations in colon cancer.3

The FDA concluded that Agena has not yet secured pre-market approval for the colon cancer test, which is called the iPLEX HS Colon Panel, or approval under the investigational device exemption. Nevertheless, the test was being shipped to laboratories for apparent non-research use since at least 2021, according to the FDA, although it had been labeled for research use only.3

The issues with Pinnacle involve the marketing of its Second Generation FIT® Fecal Immunochemical Test.

According to the FDA letter, the test is essentially an extension of Pinnacle’s fecal occult blood test, which is an over-the-counter assay for home use. Pinnacle has been marketing the test as a way to definitively test for colon cancer. As a result, the agency concluded Pinnacle is distributing the test for a new use without obtaining prior regulatory approval.4

A review of Pinnacle’s online marketing materials indicates it has changed the copy about the test to conform with its original claims that it is an “aid in the detection of colorectal cancer, diverticulitis, colitis, and Crohn’s disease.”5

The warning letter to Cue Health, sent on May 9, deals with two of the company’s COVID-19 tests—the Cue Health COVID-19 Test and the Cue Health COVID-19 Test for Home and Over The Counter (OTC) Use. Though these tests received Emergency Use Authorization (EUA) in June 2020 and March 2021, respectively, the FDA found that Cue was not complying with the conditions of these EUAs, as the company had made “significant” changes to the products without authorization that negatively impacted test performance. The FDA also stated that Cue was not taking adequate steps to “ensure that the product released meets the clinical and analytical performance claimed in the authorized labeling.”6

In addition to the warning letter, the FDA also sent out a Safety Communication on May 13 encouraging healthcare providers, caregivers, and the general public not to use the Cue COVID-19 tests “due to increased risk of false results.”7

Just over a week later, multiple media outlets reported that Cue plans to lay off its remaining employees and shut down.8

Typically, the FDA gives the subjects of warning letters 15 working days to address the deficiencies stated in the letters. The FDA may also schedule follow-up inspections within 30 days of issuing the letter.9

Asked by email if any of the four companies had yet responded to the warning letters, a communications officer for the FDA’s Center for Devices and Radiological Health declined to answer, stating that the “FDA generally does not discuss compliance matters, except with the company involved.”

Responding to an FDA Form 483 or warning letter

According to the FDA Group, businesses on the receiving end of an FDA 483 or warning letter should immediately create a corrective plan. Response letters to the FDA should also be carefully crafted and always keep the intended audience in mind.9

“Officials at FDA headquarters will ultimately be deciding on which actions to take after reviewing your response. As such, it should be written to persuade these officials that your proposed actions for correcting and preventing problems are adequate. Language should be compelling,” the FDA Group advises. “Write clear, factual, well-supported descriptions of events, systems, procedures, and other information relevant to the situation at hand.”9

Moreover, the response should be comprehensive and perhaps even a little contrite.

“Explain what you plan to do to correct the violations listed in the observations and prevent recurrence. Assure the FDA that you take the public’s health seriously by thoroughly investigating the issues, providing robust actions, and ensuring timely corrections for continuous improvement,” the FDA Group recommends.9


  1. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations
  2. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/beckman-coulter-inc-678042-03152024
  3. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agena-bioscience-inc-665159-03212024
  4. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-labs-tennessee-llc-dba-pinnacle-biolabs-676367-04172024
  5. https://www.pblabs.com/products/second-generation-fit-fecal-immunochemical-test-2-pack
  6. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cue-health-inc-675673-05092024
  7. https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication
  8. https://finance.yahoo.com/news/cue-health-lay-off-remaining-165945667.html
  9. https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Compliance-and-Product-Quality.pdf
  10. https://www.thefdagroup.com/hubfs/Downloads/The_Emergency_Guide_to_FDA_Warning_Letters_and_FDA_483.pdf


Tests and related products approved by the FDA in the past month include:

New FDA Approvals

Manufacturer Product Clearance Date
Hologic Aptima® HBV Quant Assay Pre-Market May 8, 2024
Ortho Clinical Diagnostics VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack 510(k) May 8, 2024
Lactation Lab Inc. Emily’s Care Lactation Nourish Test System (Model 1) 510(k) May 3, 2024
Geneoscopy ColoSense® for the detection of colorectal neoplasia associated RNA markers Pre-Market May 3, 2024
Roche Diagnostics cobas® pulse blood glucose monitoring system 510(k) April 26, 2024
Source: FDA Premarket Approval (PMA) and 510(k) Premarket Notification databases.

New CE marks and global certifications

Significant EU or global approvals announced during the period:

Manufacturer Product Clearance Date
Xiaogan Kuohai Medical Technology Co., Ltd. Eight approvals for a microtome device New Device February 2, 2024
Source: European Commission EUDAMED – European Database on Medical Devices.

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