The Diagnostics Pipeline: Diagnostics Make Up One-Third of Total 2023 Recalls

The summer of FDA diagnostics recalls and user warnings continues. The most recent recalls involve direct-to-consumer pregnancy and women’s health tests from Universal Medtech Inc. (UMI) and cardiac triage panels from QuidelOrtho. Of the overall 11 medical device-related announcements of 2023 so far, four now involve diagnostics, according to data from the FDA’s Recalls, Market Withdrawals, & Safety Alerts webpage.¹

Earlier, in a February 2023 announcement, UMI recalled 56,300 of its Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits, while SD Biosensor requested in May 2023 that customers stop using its Specific Pilot™ COVID-19 At-Home Tests due to microbial contamination.^2,3

UMI Recalls 16 Consumer Pregnancy and Women’s Health Tests

On August 11, the FDA issued a warning to patients and consumers against the use of over a dozen different direct-to-consumer pregnancy and women’s health tests manufactured by (UMI after the company notified the agency that it has ceased all operations and is no longer providing support for the tests. “The FDA is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe and effective,” the agency cautioned.⁴

UMI has recalled the tests that it sent to its distributors. However, the recall does not cover the tests that distributors had already sold to consumers online under their own brand names, without necessarily identifying UMI as the manufacturer. At least four different distributors are known to have sold the UMI tests using their own brand names, including:

• • AC&C Distribution, LLC,

• • HealthyWiser,

• • Home Health US Inc., and

• Prestige Biotech Inc.

Other distributors may have also sold the tests branded with a name other than UMI. The FDA recommends that consumers and patients should not buy or use any of the recalled products and should discard any unused tests they have already purchased. People who have already used any of the recalled tests and still require test results are encouraged to use another test from a different company and possibly discuss test results with their healthcare provider. The FDA also asked people to report any quality issues or “adverse events” related to using the recalled tests to its MedWatch Adverse Event Reporting program.⁶

QuidelOrtho Issues Class I Recall of Cardiac Panel Tests Due to False Negatives Risks

On July 17, QuidelOrtho issued what the FDA characterized a Class I recall—the most serious type—for three of the company’s Triage Cardiac Panel blood tests:⁷

• • the Quidel Triage Cardiac Panel (product code 97000HS),

• • the Quidel Triage Cardiac Panel, Troponin I (product code 97021HS), and

• the Quidel Triage Cardiac Panel, CK-MB and Troponin I (product code 97022HS).

The panels are designed to detect creatine kinase MB (CK-MB) enzyme and myoglobin and troponin I proteins in blood or plasma samples to diagnose heart attack and life-threatening injury to the heart muscle. The reason for the recall is the risk of producing false negative results.

“A falsely low or false negative troponin level may cause a delayed or missed diagnosis of myocardial infarction—a serious, potentially fatal condition that requires the earliest detection possible to treat and protect the heart muscle effectively,” the FDA recall notice says. “This poses a particular risk to people who experience a silent myocardial infarction with no other symptoms, those who have unusual or atypical symptoms, and those with non-ST-segment elevation myocardial infarction (NSTEMI).”⁷

The recalled panels were distributed starting on November 1, 2022. QuidelOrtho has directly notified customers of the issue and instructed them to discontinue use of the products while either using alternative tests or sending patients to a different laboratory that uses alternate tests for accurate results. Customers should also notify a clinician of all negative results if alternative methods are unavailable. The company has so far reported receiving 41 complaints, but no injuries or deaths related to the use of the recalled panels.

References:

1. 1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

1. 1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-nationwide-recall-skippack-medical-lab-sars-cov-2-antigen-rapid-test

1. 1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recall-notice-sd-biosensor-inc-requests-discontinuation-use-and-disposal-specific-pilottm-covid-19

1. 1. https://www.fda.gov/medical-devices/safety-communications/do-not-use-tests-manufactured-universal-meditech-inc-fda-safety-communication

1. 1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-nationwide-recall-all-products-manufactured-between-march-2021-and

1. 1. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda

1. 1. https://www.fda.gov/medical-devices/medical-device-recalls/quidel-cardiovascular-inc-recalls-quidel-triage-cardiac-panels-risk-false-negative-troponin-result

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Here are the key new laboratory testing and diagnostics products clearances that were announced in the period from mid-July 2023 to late August 2023:

New FDA Approvals & Emergency Use Authorizations (EUAs)

Manufacturer(s)	Product
PixCell Medical	510(k) clearance for direct capillary sampling with the PixCell HemoScreen™ complete blood count analyzer
Tempus	Breakthrough Device designation for HLA-LOH assay as companion diagnostic test for identifying patients with solid tumors that may benefit from specific targeted therapies
Roche	510(k) clearance for cobas SARS-CoV-2 & Influenza A/B point-of-care RT-PCR test for COVID-19 and influenza A/B
Foundation Medicine (Roche subsidiary)	FoundationOne®CDx test approved for use as a companion diagnostic for Janssen Biotech’s AKEEGA™ (niraparib and abiraterone acetate)
MiRXES	Breakthrough device designation for GASTROClear™ PCR test for early detection of gastric cancer
Abbott	510(k) clearance for Alinity® h-Series hematology system
Abbott	510(k) clearance for i-STATPTplus Cartridge prothrombin time test to quantify clot time of extrinsic coagulation pathway when activated by thromboplastin in non-anticoagulated whole blood for use with Abbott’s handheld i-STAT 1 analyzer
Abbott	510(k) clearance for i-STAT CG8+ cartridge point-of-care glucose test system for the i-STAT 1 System for quantification of glucose in whole blood for diagnosis, monitoring, and treatment of carbohydrate metabolism disorders
Abbott	510(k) clearance for Alkaline Phosphatase2 assay for quantitation of alkaline phosphatase in serum or plasma on ARCHITECT c System analyzers
QIAGEN	Clearance for therascreen PDGFRA RGQ PCR kit for use as companion diagnostic to detect a mutation in the platelet-derived growth factor receptor alpha (PDGFRA) gene associated with primary resistance to other drugs in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST)
Trinity Biotech	510(k) clearance for Premier Resolution System automated analyzer
Laboratory Corporation of America	Clearance for Clear Dx SARS-CoV-2 WGS v3.0 Test nanopore sequencing assay to detect SARS-CoV-2
Beckman Coulter (Danaher subsidiary)	510(k) clearance for DxC 500 AU Clinical Chemistry Analyzer

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New Approvals in Europe

Manufacturer(s)	Product(s)
Thermo Fisher Scientific	EXENT® Solution automated mass spectrometry system for diagnosing and assessing patients with monoclonal gammopathies, including multiple myeloma
Agilent Technologies	PD-L1 IHC 22C3 pharmDx companion diagnostic assay to identify cancer patients eligible for treatment with anti-PD-1 therapies
Geneseeq Technology	GeneseeqPrime™ and GeneseeqPrime™ HRD NGS-based kits for solid tumor genomic profiling
Geneseeq Technology	Hemasalus™ DNA/Hemarna™ RNA NGS-based kit for hematological cancer genomic profiling
Theranica	Expansion of existing CE mark for Nerivio® system to include neuromodulation armband for migraine treatment

Other international clearances announced during the period:

Manufacturer(s)	Country	Product(s)
Bionano Genomics (via its Chinese original equipment manufacturing partner, A-smart MedTech)	China	G2 direct label and stain (DLS) DNA labeling kit
Bionano Genomics (via its Chinese original equipment manufacturing partner, A-smart MedTech)	China	G2 SP bone marrow aspirate (BMA) DNA isolation kit