Laboratories under pressure
Laboratories Under Pressure
Documented events. Bounded conclusions.
These are primary-source record summaries, not newly approved news articles or a live safety-alert service. Dates distinguish the event from the source report. Historical FDA ongoing labels carry neutral indicators: openFDA does not update recall lifecycle status after classification. They do not establish a present critical alert. Allegations and settlements are also neutral. No closure, CLIA sanction or state license-loss case is asserted without an individual official record.
Historical posture is shown as stated by the source; later case developments may not be reflected. A recall is not evidence of laboratory insolvency. This is not medical or investment advice.
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6 verified records
- Civil settlementSettled; no liability determination
DermTech settlement gave the United States an allowed $5,038,011 unsecured bankruptcy claim
DermTech Inc. (bankrupt; distinct from DermTech LLC) · Event date
DOJ reported that the United States received an Allowed Class Three General Unsecured Claim of $5,038,011 in the bankruptcy proceeding as part of a settlement resolving allegations concerning Medicare claims for skin cancer tests. The settlement resolves allegations, not a determination of liability.[1]
Evidence & source limits
Distinction: An allowed bankruptcy claim is not proof of a cash payment or recovery. The allegations concern bankrupt DermTech Inc., not DermTech LLC, the asset buyer; DOJ states there has been no determination of liability.
[1] DermTech Inc. to Pay Up to $5M to Resolve Allegations It Submitted False Claims to Medicare for Unreliable Skin Cancer Tests — U.S. Attorney's Office, S.D. California (DOJ). Source date 2026-08-26; last source check Nov 7, 2026. Primary evidence; company statements are attributed. Status is the source's historical posture, not a live case check.
- Civil settlementSettled; Corporate Integrity Agreement
Access DX Laboratory and two individuals agreed to pay a combined $36.4M to settle kickback and genetic-testing allegations
Access DX Laboratory (Houston, Texas) · Event date
The Justice Department said Access DX Laboratory, its former CEO and a Florida businessman each entered settlements totaling $36.4 million to resolve False Claims Act allegations of kickbacks and billing for unnecessary genetic testing. Access DX also entered a five-year Corporate Integrity Agreement with HHS-OIG.[2]
Evidence & source limits
Distinction: The laboratory's civil settlement resolves allegations. Separate guilty-plea agreements by the two individuals, described in the release, are criminal matters and are not admissions by the laboratory.
[2] Texas Laboratory, Former CEO, and Florida Businessman Pay a Total of $36.4M to Settle Allegations of Kickbacks and Unnecessary Genetic Testing — U.S. Department of Justice, Office of Public Affairs. Source date 2026-07-30; last source check Nov 7, 2026. Primary evidence; company statements are attributed. Status is the source's historical posture, not a live case check.
- Guilty plea agreement and civil settlementCivil settlement; plea agreed
South Carolina's former Labtech Diagnostics agreed to plead guilty and pay at least $6.8M
LTD Holding LLC, formerly Labtech Diagnostics LLC (Anderson, South Carolina) · Event date
The Justice Department said Labtech and its founder agreed to pay at least $6.8 million (plus up to about $3.27 million more if a financial contingency occurs) to resolve False Claims Act kickback allegations. Separately, Labtech agreed to plead guilty to five Anti-Kickback Statute counts and pay $103,551.90 in restitution.[3]
Evidence & source limits
Distinction: Two tracks: the civil settlement resolves allegations; the criminal track is the company's agreement to plead guilty, as described by DOJ on the release date.
[3] South Carolina Laboratory Pleads Guilty and Agrees to Pay At Least $6.8M to Settle Allegations of Kickbacks to Doctors — U.S. Department of Justice, Office of Public Affairs. Source date 2026-01-07; last source check Nov 7, 2026. Primary evidence; company statements are attributed. Status is the source's historical posture, not a live case check.
- RecallFDA record: ongoing (dataset 2026-10-28)
Beckman Coulter initiated a Class II recall of specified bicarbonate reagent lots
Beckman Coulter Ireland Inc. · Event date
FDA enforcement record Z-0997-2026 identifies a voluntary recall of specified bicarbonate reagent lots, references OSR6137, OSR6237 and OSR6637, for AU analyzers. FDA records potential falsely elevated bicarbonate results from lactate dehydrogenase interference. The firm initiated the recall on October 14, 2025; FDA classified it on December 23, 2025.[4]
Evidence & source limits
Distinction: A product-lot recall is not laboratory closure, insolvency or a company-wide safety finding. The FDA dataset, last updated October 28, 2026, lists the recall as ongoing; this does not independently establish present exposure or affected product availability.
[4] FDA Device Enforcement Report Z-0997-2026 — Beckman Coulter bicarbonate — U.S. Food and Drug Administration (openFDA). Source date 2025-12-31; last source check Nov 7, 2026. Primary evidence; company statements are attributed. Status is the source's historical posture, not a live case check.
- Subsidiary Chapter 11Case filed; jointly administered
ProPhase Labs' diagnostic laboratory subsidiaries filed for Chapter 11
ProPhase Labs (subsidiaries: ProPhase Diagnostics, Inc.; ProPhase Diagnostics NY, Inc.; ProPhase Diagnostics NJ, Inc.) · Event date
ProPhase Labs' quarterly report states that on September 22, 2025 its wholly owned subsidiary ProPhase Diagnostics, Inc. and two indirectly wholly owned subsidiaries filed for Chapter 11 reorganization in the U.S. Bankruptcy Court for the District of New Jersey; the court granted joint administration on September 30, 2025.[5]
Evidence & source limits
Distinction: The filing entities are the three diagnostic subsidiaries. The 10-Q does not describe ProPhase Labs, the parent, as a debtor in this case.
[5] Form 10-Q for the quarterly period ended June 30, 2026 (Chapter 11 and deconsolidation note) — ProPhase Labs, Inc. (SEC filing). Source date 2026; last source check Nov 7, 2026. Primary evidence; company statements are attributed. Status is the source's historical posture, not a live case check.
- RecallFDA record: ongoing (dataset 2026-10-28)
Ortho-Clinical Diagnostics recalled specified VITROS lactate slide lots
Ortho-Clinical Diagnostics, Inc. · Event date
FDA enforcement record Z-2560-2025 identifies a voluntary Class II recall of specified VITROS Chemistry Products LAC slide lots, catalog 8150112, from coatings 0130 and above. FDA describes increased calibration failures on VITROS XT 3400 and XT 7600 systems that could delay lactate results. The firm initiated the recall on July 29, 2025; FDA classified it on September 12, 2025.[6]
Evidence & source limits
Distinction: The notice concerns identified lots and systems, not all VITROS products or all laboratories using them. The FDA dataset, last updated October 28, 2026, lists the recall as ongoing; the record does not establish current patient exposure or company financial distress.
[6] FDA Device Enforcement Report Z-2560-2025 — VITROS LAC Slides — U.S. Food and Drug Administration (openFDA). Source date 2025-09-24; last source check Nov 7, 2026. Primary evidence; company statements are attributed. Status is the source's historical posture, not a live case check.
Corrections: if a record is inaccurate or its status changes, we update it with a dated correction note. See our corrections policy or contact the editors.