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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88797

16 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 22, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
bioMerieux, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

16 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 16

VIDAS PRG Progesterone, REF 30409-01

Z-0424-2022
Recall number
Z-0424-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
1818 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution.

device · product 2 of 16

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

Z-0425-2022
Recall number
Z-0425-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026229146, Lot #s: 1008730880

Distribution pattern

US Nationwide distribution.

device · product 3 of 16

VIDAS Clostridium Difficile GDH, REF 30125-01

Z-0426-2022
Recall number
Z-0426-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026444204, Lot #s: 1008686690

Distribution pattern

US Nationwide distribution.

device · product 4 of 16

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

Z-0427-2022
Recall number
Z-0427-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
1579

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution.

device · product 5 of 16

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

Z-0428-2022
Recall number
Z-0428-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
28430

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution.

device · product 6 of 16

VIDAS Mumps IgG (MPG), REF 30218

Z-0429-2022
Recall number
Z-0429-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
One lot

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026064525, Lot #: 1008769120

Distribution pattern

US Nationwide distribution.

device · product 7 of 16

VIDAS Measles IgG (MSG), REF 30219

Z-0430-2022
Recall number
Z-0430-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
One lot

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026064532, Lot #: 1008890110

Distribution pattern

US Nationwide distribution.

device · product 8 of 16

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

Z-0431-2022
Recall number
Z-0431-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
One lot

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026263010, Lot #: 1008861590

Distribution pattern

US Nationwide distribution.

device · product 9 of 16

VIDAS RUB IgG (RBG), REF 30226

Z-0432-2022
Recall number
Z-0432-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
Three lots

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026138585, Lot #: 1008694980, 1008700260, 1008828980

Distribution pattern

US Nationwide distribution.

device · product 10 of 16

VIDAS LH, REF 30406-01

Z-0433-2022
Recall number
Z-0433-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
One lot

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026156930, Lot #: 1008848600

Distribution pattern

US Nationwide distribution.

device · product 11 of 16

VIDAS FSH, REF 30407-01

Z-0434-2022
Recall number
Z-0434-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
One lot

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026156947, Lot #: 1008781470

Distribution pattern

US Nationwide distribution.

device · product 12 of 16

VIDAS Estradiol II, REF 30431-01

Z-0435-2022
Recall number
Z-0435-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
One lot

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026161637, Lot #: 1008757880

Distribution pattern

US Nationwide distribution.

device · product 13 of 16

VIDAS Lyme IgM II (LYM), REF 416436

Z-0436-2022
Recall number
Z-0436-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
Three lots

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026447151, Lot #: 1008636750, 1008768920, 1008857410

Distribution pattern

US Nationwide distribution.

device · product 14 of 16

VIDAS Lyme IgG II (LYM), REF 417401

Z-0437-2022
Recall number
Z-0437-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
Two lots

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026458270, Lot #: 1008714880, 1008824220

Distribution pattern

US Nationwide distribution.

device · product 15 of 16

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

Z-0438-2022
Recall number
Z-0438-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
One lot

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026620738, Lot #: 1008710950

Distribution pattern

US Nationwide distribution.

device · product 16 of 16

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

Z-0439-2022
Recall number
Z-0439-2022
Initiated
September 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
bioMerieux, Inc.
Quantity
Two lots

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI 03573026620745, Lot #: 1008671430, 1008763910

Distribution pattern

US Nationwide distribution.