VITEK2 GP-ID, REF 21342 IVD

Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in associ…

Recall #: Z-0074-2018
Affected scope: 5672 cartons
Initiated: October 11, 2017

Compiled from official public sources by the publisher. · Updated September 2026

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Biomerieux Inc recalled VITEK2 GP-ID, REF 21342 IVD - a moderate-severity action.

VITEK2 GP-ID, REF 21342 IVD was recalled by Biomerieux Inc in November 15, 2017. Reason: Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R …. Check the official notice for the remedy. Verify recall #Z-0074-2018 with the FDA Devices before acting.

The recall

Biomerieux Inc issued this moderate-severity FDA Devices recall-Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R ….

Moderate
severity level: Class II
classification: November 15, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0074-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

VITEK2 GP-ID, REF 21342 IVD

Reason for recall

Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0074-2018
Date reported	November 15, 2017
Date initiated	October 11, 2017
Recalling firm	Biomerieux Inc
Firm location	Hazelwood, MO
Affected scope	5672 cartons
Distribution	worldwide

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0074-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

VITEK2 GP-ID, REF 21342 IVD. Recalled by Biomerieux Inc. Units affected: 5672 cartons.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 15, 2017. Severity: Moderate. Recall number: Z-0074-2018.

Where was the recalled product distributed? ▼

Distribution: worldwide.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported November 15, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026