Is VIDAS PRG Progesterone, REF 30409-01 recalled?

Medium RiskFDA Device

bioMerieux, Inc.: 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.

Agency Publication Date: December 28, 2021

Affected Products

Product: VIDAS PRG Progesterone, REF 30409-01

UDI 03573026064952, Lot #s: 1008685490, 1008766980, 1008775630, 1008873180, 1008911240

Product: VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01

UDI 03573026229146, Lot #s: 1008730880

Product: VIDAS Clostridium Difficile GDH, REF 30125-01

UDI 03573026444204, Lot #s: 1008686690

Product: VIDAS DEX@, Dimer Exclusion II, REF 30455-01

UDI 03573026387006, Lot #s: 1008696660,1008761020, 1008864290, 1008891690

Product: VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01

UDI 03573026223601, Lot #s: 1008603580, 1008748010, 1008888030, 1008584190, 1008647850

Product: VIDAS Mumps IgG (MPG), REF 30218

UDI 03573026064525, Lot #: 1008769120

Lot Numbers:

1008769120

Product: VIDAS Measles IgG (MSG), REF 30219

UDI 03573026064532, Lot #: 1008890110

Lot Numbers:

1008890110

Product: VIDAS TOXO IgG Avidity (TXGA), REF 30222-01

UDI 03573026263010, Lot #: 1008861590

Lot Numbers:

1008861590

Product: VIDAS RUB IgG (RBG), REF 30226

UDI 03573026138585, Lot #: 1008694980, 1008700260, 1008828980

Lot Numbers:

1008694980

Product: VIDAS LH, REF 30406-01

UDI 03573026156930, Lot #: 1008848600

Lot Numbers:

1008848600

Product: VIDAS FSH, REF 30407-01

UDI 03573026156947, Lot #: 1008781470

Lot Numbers:

1008781470

Product: VIDAS Estradiol II, REF 30431-01

UDI 03573026161637, Lot #: 1008757880

Lot Numbers:

1008757880

Product: VIDAS Lyme IgM II (LYM), REF 416436

UDI 03573026447151, Lot #: 1008636750, 1008768920, 1008857410

Lot Numbers:

1008636750

Product: VIDAS Lyme IgG II (LYM), REF 417401

UDI 03573026458270, Lot #: 1008714880, 1008824220

Lot Numbers:

1008714880

Product: VIDAS SARS-COV-2 IgM, Ref 423833-01

UDI 03573026620738, Lot #: 1008710950

Lot Numbers:

1008710950

Product: VIDAS SARS-COV-2 IgG, Ref 423834-01

UDI 03573026620745, Lot #: 1008671430, 1008763910

Lot Numbers:

1008671430

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88797

Status: Active

Manufacturer: bioMerieux, Inc.

Manufactured In: United States

Units Affected: 16 products (1818 units; 50; 50; 1579; 28430; One lot; One lot; One lot; Three lots; One lot; One lot; One lot; Three lots; Two lots; One lot; Two lots)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: VIDAS PRG Progesterone, REF 30409-01

UDI 03573026064952, Lot #s: 1008685490, 1008766980, 1008775630, 1008873180, 1008911240

Product: VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01

UDI 03573026229146, Lot #s: 1008730880

Product: VIDAS Clostridium Difficile GDH, REF 30125-01

UDI 03573026444204, Lot #s: 1008686690

Product: VIDAS DEX@, Dimer Exclusion II, REF 30455-01

UDI 03573026387006, Lot #s: 1008696660,1008761020, 1008864290, 1008891690

Product: VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01

UDI 03573026223601, Lot #s: 1008603580, 1008748010, 1008888030, 1008584190, 1008647850

Product: VIDAS Mumps IgG (MPG), REF 30218

UDI 03573026064525, Lot #: 1008769120

Lot Numbers:

1008769120

Product: VIDAS Measles IgG (MSG), REF 30219

UDI 03573026064532, Lot #: 1008890110

Lot Numbers:

1008890110

Product: VIDAS TOXO IgG Avidity (TXGA), REF 30222-01

UDI 03573026263010, Lot #: 1008861590

Lot Numbers:

1008861590

Product: VIDAS RUB IgG (RBG), REF 30226

UDI 03573026138585, Lot #: 1008694980, 1008700260, 1008828980

Lot Numbers:

1008694980

Product: VIDAS LH, REF 30406-01

UDI 03573026156930, Lot #: 1008848600

Lot Numbers:

1008848600

Product: VIDAS FSH, REF 30407-01

UDI 03573026156947, Lot #: 1008781470

Lot Numbers:

1008781470

Product: VIDAS Estradiol II, REF 30431-01

UDI 03573026161637, Lot #: 1008757880

Lot Numbers:

1008757880

Product: VIDAS Lyme IgM II (LYM), REF 416436

UDI 03573026447151, Lot #: 1008636750, 1008768920, 1008857410

Lot Numbers:

1008636750

Product: VIDAS Lyme IgG II (LYM), REF 417401

UDI 03573026458270, Lot #: 1008714880, 1008824220

Lot Numbers:

1008714880

Product: VIDAS SARS-COV-2 IgM, Ref 423833-01

UDI 03573026620738, Lot #: 1008710950

Lot Numbers:

1008710950

Product: VIDAS SARS-COV-2 IgG, Ref 423834-01

UDI 03573026620745, Lot #: 1008671430, 1008763910

Lot Numbers:

1008671430