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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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Critical RiskFDA Device

Remel Inc: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

Agency Publication Date: December 8, 2022
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Affected Products

Product: Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST

Lot Numbers: B2232B, B2197, B2012, B1355, B1181, B1173, B1125A

Lot Numbers:
Numbers
Product: Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST

Lot Numbers: B2247, B2096, B1445, B1263, B1176, B0503A

Lot Numbers:
Numbers
Product: Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST

Lot Numbers: B2317, B2267, B2251, B2177, B2086, B2037, B2034B, B1476, B1424, B1384, B1286, B1215, B1182, B1104, B1051, B1021

Lot Numbers:
Numbers
Product: Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST

Lot Numbers: B2206A, B2035A, B1333, B1144A, B0483

Lot Numbers:
Numbers
Product: Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST

Lot Numbers: B2125, B2115

Lot Numbers:
Numbers
Product: Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST

Lot Numbers: B2281, B2151A, B2034, B1453

Lot Numbers:
Numbers
Product: Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST

Lot Numbers: B2311B

Lot Numbers:
Numbers
Product: Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST

Lot Numbers: B2314, B2174, B2036, B1346, B1183, B1115, B1027

Lot Numbers:
Numbers
Product: Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST

Lot Numbers: B2265A

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91104
Status: Resolved
Manufacturer: Remel Inc
Manufactured In: United States
Units Affected: 9 products (1917 units; 2471 units; 8073 units; 665 units; 588 units; 1647 units; 70 units; 2656 units; 9 units)

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.