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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Microbiologics Inc: Product with incorrect shelf life.

Agency Publication Date: June 4, 2019
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Affected Products

Product: Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

Cepheid Xpert MRSA/MRSA NxG Control Panel Catalog Number 8195 Lot Numbers: 8195-02, 8195-03, 8195-04, 8195-05, 8195-06, 8195-07, 8195-08, 8195-09, and 8195-10. Cepheid Xpert¿ SA Nasal Complete Control Panel Catalog Number 8196 Lot Numbers: 8196-04, 8196-05, 8196-06, 8196-07, 8196-08 8196-09, 8196-10, and 8196-14.

Lot Numbers:
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Product: Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

Cepheid Xpert¿ SA Nasal Complete Control Panel Catalog Number 8196 Lot Numbers: 8196-04, 8196-05, 8196-06, 8196-07, 8196-08 8196-09, 8196-10, and 8196-14.

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82783
Status: Active
Manufacturer: Microbiologics Inc
Manufactured In: United States
Units Affected: 2 products (249; 235)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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.