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VIDAS® Progesterone 30409-01Recalls & reported problems

Biomerieux SA · VIDAS ® Progesterone (PRG) assay is a quantitative IA intended for use on VIDAS family instrument in the determination of progesterone concentration in human serum or plasma. · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026156954), received between Nov 10, 2021 and Nov 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unable to Obtain Readings” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Nov 9, 2022Class IIOpen, Classified

    As the temperature and time out of range was exceeded, product performances cannot be guaranteed

    Z-0866-2023 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Device problems

  • Unable to Obtain Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 10, 2021Unable to Obtain Readings; Unable to Obtain Readings

    ON (B)(6) 2021, A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A SUBSTRATE ERROR WHILE USING THE VIDAS® PROGESTERONE 60 TESTS KIT (REFERENCE # 30409-01, LOT # 1008775630). IN THE CASE OF A SUBSTRATE ERROR, AN ERROR MESSAGE IS DISPLAYED ON THE EQUIPMENT VISIBLE BY THE USER, AND IT IS IMPOSSIBLE TO RUN TESTS AND GENERATE RESULTS. AT THE TIME OF THIS ASSESSMENT, THERE IS NO INFORMATION REGARDING DELAYS FOR ANY PATIENT SAMPLES. HOWEVER, IF THE CUSTOMER DOES NOT HAVE AN ALTERNATIVE TESTING METHOD, THIS COULD POTENTIALLY LEAD TO DELAYED PATIENT TEST RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THE LOT IMPACTED BY THIS COMPLAINT IS PART OF THE SCOPE OF FSCA (B)(4) FOR SUBSTRATE ERROR ON MULTIPLE VIDAS® PRODUCT REFERENCES THAT WAS RELEASED ON (B)(6) 2021. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12789720 ↗

Other RADIOIMMUNOASSAY, PROGESTERONE devices

All RADIOIMMUNOASSAY, PROGESTERONE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page