Biomerieux Sa
CHEMIN DE L ORME, MARCY L ETOILE Rhone, FR
Registered product codes
31 product codes
Recent MDR events
1,762 on file
- VIDAS® BRAHMS PROCALCITONINJun 12, 2025Malfunction8020790-2025-00009
- VIDAS® BRAHMS PROCALCITONINJun 12, 2025Malfunction8020790-2025-00010
- VIDAS® ESTRADIOL IIApr 10, 2025Malfunction8020790-2025-00006
- VIDAS® ESTRADIOL IIApr 4, 2025Malfunction8020790-2025-00004
- VIDAS® ESTRADIOL IIApr 4, 2025Malfunction8020790-2025-00005
- BIOFIRE TORCH GI PANELFeb 28, 2025MalfunctionMW5167054
- BIOFIRE TORCH GI PANELFeb 28, 2025MalfunctionMW5167056
- BIOFIRE TORCH GI PANELFeb 28, 2025MalfunctionMW5167057
- FILM ARRAY GI PANEL KITFeb 25, 2025InjuryMW5166804
- FILM ARRAY GI PANEL KITFeb 25, 2025InjuryMW5166807
Recalls
45 on file
- TerminatedJun 29, 2018
Invalid calibration with low calibrator S1 while using the product.
View FDA record ↗ - TerminatedDec 19, 2017
QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
View FDA record ↗ - TerminatedDec 19, 2017
QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
View FDA record ↗ - TerminatedMay 3, 2017
False susceptible results
View FDA record ↗ - TerminatedMay 3, 2017
Potential performance issue on strain categorization.
View FDA record ↗ - TerminatedMar 21, 2017
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View FDA record ↗ - TerminatedMar 21, 2017
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View FDA record ↗ - TerminatedMar 21, 2017
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View FDA record ↗ - TerminatedMar 21, 2017
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View FDA record ↗ - TerminatedMar 21, 2017
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View FDA record ↗
Compliance history
Matched by FEI 1000611339.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.