Remel Inc Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Brand
Remel Inc
Lot Codes / Batch Numbers
Product Number MDRGN2F
Products Sold
Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)
Remel Inc is recalling Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format due to There are lower than expected MICs for some gram negative species.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There are lower than expected MICs for some gram negative species.
Recommended Action
Per FDA guidance
A customer letter was issued to impacted consignees on or around 01/10/2022. Customers are asked to check for affected product and the recalling firm requests that customers do not report results of cefiderocol when affected product is used with Thermo Scientific Mueller-Hinton Broth with TES, catalong T3462, lots 267261 to 402775. Consignees are asked to disseminate the recall information within their organization and to any other organization to which affected products have been transferred. An acknowledgement form should be submitted by email to MBD.vigilance@thermofisher.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026