FDA Device

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Hazard

There are lower than expected MICs for some gram negative species.

What You Should Do

Remedy

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.

Products

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Brand
Remel Inc
UPC
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)

Units Affected

1210 devices