Z-1425-2021Class II

Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium...

Name: Z-1425-2021 Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium...
Creator: Remel Inc
Published: 2021-03-10
License: https://open.fda.gov/license/

Remel Inc / initiated 2021-03-10 / Open, Classified

FDA source

Remel Inc began a recall of Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by... on 2021-03-10. FDA classified it as Class II and gives the reason as "When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1425-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-10
Posted: 2021-04-13
Recalling firm: Remel Inc
Product: Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
FDA root cause: Under Investigation by firm
Action: The firm, ThermoFisher Scientific, sent an "Medical Device Field Action Recall" letter dated 3/10/2021 to its consignees on 03/10/2021. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: Review the reported test results should be determined by the appropriate technical expert. Please keep this notification on file. 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 Technical Services Department at 800-255-6730 (US) or email [email protected]. You should complete the accompany Acknowledgment Form upon receipt and return to [email protected]. If you have any further questions, contact Director, Quality Assurance and Regulatory Affairs at 913-895-4077 or email: [email protected] Copy to: Beverly Marsh - [email protected].
Quantity in commerce: 19 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Numbers: Lot 220711 Exp. 2021-2-17

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1425-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1424-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-13
Z-1425-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-13

Product code JSO

K892928Class IIHaemophilus Test Medium (Agar)Remel Co. / cleared 1989-06-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)