—#186186

Product

Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 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.

FDA product code: JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K892928
Affected lot / code info: Lot Numbers: 201334 Exp. 2021-01-21, 210892 Exp. 2021-02-03, 217048 Exp. 2021-02-10

Why it was recalled

When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 microbiology.ts.us@thermofisher.com. You should complete the accompany Acknowledgment Form upon receipt and return to MBD.vigilance@thermofisher.com. If you have any further questions, contact Director, Quality Assurance and Regulatory Affairs at 913-895-4077 or email: gary.klaassen@thermofisher.com Copy to: Beverly Marsh - beverly.marsh@thermofisher.com.

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-03-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186186. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.