Z-1947-2025Class II

Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF...

Name: Z-1947-2025 Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF...
Creator: Remel, Inc
Published: 2025-05-01
License: https://open.fda.gov/license/

Remel Inc / initiated 2025-05-01 / Open, Classified

FDA source

Remel, Inc began a recall of Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device on 2025-05-01. FDA classified it as Class II and gives the reason as "Product may have an off color affecting perfomance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1947-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-01
Posted: 2025-06-11
Recalling firm: Remel Inc
Product: Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Product may have an off color affecting perfomance
FDA root cause: Under Investigation by firm
Action: Thermo Fisher Scientific issued an Urgent: Medical Device Recall notice to its consignees on 05/01/2025 via USPS First Class Mail. The notice explained the issue with the device, potential risk to health, and requested the following: "Accordingly, in keeping with our Quality Policy, we request that a review of test results should be evaluated by an appropriate technical expert. Please keep this notification on file. Also, destroy any remaining inventory of the lot listed above and complete the accompanying Acknowledgement form. Return the completed form indicating number of units destroyed via email to [email protected] for your replacement/credit to be processed. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email [email protected]."
Quantity in commerce: 70 units
Distribution: Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
Product codes and lots: UDI/DI 848838018855, lot 226414

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1947-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1947-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11

Product code JWY

K111429Class IISensititre (R) Hp Mic Susceptibility Plate with Cefaroline (0.004-8Ug/ml) and the Sensititre (R) 18-24 Hour Mic Susce...Trek Diagnostic Systems, Ltd. / cleared 2011-08-18

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)