Food, drugs, devices › bioMerieux, Inc.
Device recall: VIDAS PRG Progesterone, REF 30409-01
bioMerieux, Inc. (Durham, NC) initiated this device recall on 22 Sep 2021; FDA lists 16 product records under event 88797, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. bioMerieux, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
bioMerieux, Inc., Durham, NC.
Reason for recall
"bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0424-2022 | VIDAS PRG Progesterone, REF 30409-01 | 1818 units | Class II | Ongoing | 5 Jan 2022 |
| Z-0425-2022 | VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01 | 50 | Class II | Ongoing | 5 Jan 2022 |
| Z-0426-2022 | VIDAS Clostridium Difficile GDH, REF 30125-01 | 50 | Class II | Ongoing | 5 Jan 2022 |
| Z-0427-2022 | VIDAS DEX@, Dimer Exclusion II, REF 30455-01 | 1579 | Class II | Ongoing | 5 Jan 2022 |
| Z-0428-2022 | VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01 | 28430 | Class II | Ongoing | 5 Jan 2022 |
| Z-0429-2022 | VIDAS Mumps IgG (MPG), REF 30218 | One lot | Class II | Ongoing | 5 Jan 2022 |
| Z-0430-2022 | VIDAS Measles IgG (MSG), REF 30219 | One lot | Class II | Ongoing | 5 Jan 2022 |
| Z-0431-2022 | VIDAS TOXO IgG Avidity (TXGA), REF 30222-01 | One lot | Class II | Ongoing | 5 Jan 2022 |
| Z-0432-2022 | VIDAS RUB IgG (RBG), REF 30226 | Three lots | Class II | Ongoing | 5 Jan 2022 |
| Z-0433-2022 | VIDAS LH, REF 30406-01 | One lot | Class II | Ongoing | 5 Jan 2022 |
| Z-0434-2022 | VIDAS FSH, REF 30407-01 | One lot | Class II | Ongoing | 5 Jan 2022 |
| Z-0435-2022 | VIDAS Estradiol II, REF 30431-01 | One lot | Class II | Ongoing | 5 Jan 2022 |
| Z-0436-2022 | VIDAS Lyme IgM II (LYM), REF 416436 | Three lots | Class II | Ongoing | 5 Jan 2022 |
| Z-0437-2022 | VIDAS Lyme IgG II (LYM), REF 417401 | Two lots | Class II | Ongoing | 5 Jan 2022 |
| Z-0438-2022 | VIDAS SARS-COV-2 IgM, Ref 423833-01 | One lot | Class II | Ongoing | 5 Jan 2022 |
| Z-0439-2022 | VIDAS SARS-COV-2 IgG, Ref 423834-01 | Two lots | Class II | Ongoing | 5 Jan 2022 |
Context
Other enforcement events for bioMerieux, Inc.
All 57 events for bioMerieux, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.