Recalls / —

—#191507

Product

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

FDA product code

JWY — Manual Antimicrobial Susceptibility Test Systems

Device class

Class 2

Medical specialty

Microbiology

510(k) numbers

K193538

Affected lot / code info

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)

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Remel Inc

Address

12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern

Distribution throughout the United States.

Timeline

Recall initiated

2022-01-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #191507. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.