Z-0722-2022Class II

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Name: Z-0722-2022 Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Creator: Remel Inc
Published: 2022-01-10
License: https://open.fda.gov/license/

Remel Inc / initiated 2022-01-10 / Open, Classified

FDA source

Remel Inc began a recall of Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format on 2022-01-10. FDA classified it as Class II and gives the reason as "There are lower than expected MICs for some gram negative species". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0722-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-10
Posted: 2022-03-04
Recalling firm: Remel Inc
Product: Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: There are lower than expected MICs for some gram negative species.
FDA root cause: Under Investigation by firm
Action: 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 [email protected].
Quantity in commerce: 1210 devices
Distribution: Distribution throughout the United States.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0722-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0722-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-16	2022-03-04

Product code JWY

K193538Class IISensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/mlThermo Fisher Scientific / cleared 2020-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)