Remel Inc: Medical Device Recall in 2022 - (Recall #: Z-0722-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Product Classification:

Class II

Date Initiated: January 10, 2022

Date Posted: March 16, 2022

Recall Number: Z-0722-2022

Event ID: 89416

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1210 devices

Code Information:

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)

Distribution Pattern:

Distribution throughout the United States.

Voluntary or Mandated:

Voluntary: Firm initiated