BIOMERIEUX SA FDA Inspection Record
BIOMERIEUX SA is an FDA-registered facility (FEI 1000611339) located in MARCY L ETOILE Rhone, FR. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jun 22, 2017: No Action Indicated (NAI)
- Inspections on record
- 2 (2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 21, latest Sep 11, 2026
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 22, 2017 | No Action Indicated (NAI) | No citations listed |
| Nov 18, 2010 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 11, 2026 | Class II | Z-0301-2027 | EMAG system
Model/Catalog Number: 418591/418591U
Product Description: Nucleic acid… Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error… |
| Jun 22, 2021 | Class II | Z-2225-2021 | MYLA software. Used to manage microbiology test workflow from the reception of requests… Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature. |
| Sep 17, 2018 | Class II | Z-0218-2019 | NucliSENS¿ Magnetic Extraction Reagents Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product. |
| Apr 9, 2018 | Class II | Z-2331-2018 | VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA… Invalid calibration with low calibrator S1 while using the product. |
| Mar 23, 2018 | Class II | Z-2164-2018 | The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2… and 8 more products A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue… |
| Oct 18, 2017 | Class II | Z-0086-2018 | NucliSENS Lysis Buffer
Extended lot for RES 76675 Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as… |
| Apr 25, 2017 | Class II | Z-2095-2017 | ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging
ETEST is a quantitative… False susceptible results |
| Apr 13, 2017 | Class II | Z-0264-2018 | ETEST OXACILLIN OX 256 US F100
In vitro diagnostic, a quantitative technique for… and 1 more product QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518)… |
| Mar 17, 2017 | Class II | Z-1801-2017 | VIDAS Estradiol II, Ref 30431-01, 60 tests
The VIDAS Estradiol II (E2 II) assay is… Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with… |
| Mar 7, 2017 | Class II | Z-1713-2017 | NucliSENS Lysis Buffer, REF 200292
NucliSENS Lysis Buffer is intended to be use for the… Problem with colored eluates for whole blood extractions |
Facility details
- Company
- BioMerieux SA
- Location
- MARCY L ETOILE Rhone (FR)
- Source
- device