FDA-Device2023-07-05Class II

Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.

Remel, Inc
Hazard

The test medium may not perform as intended.

Sold states
Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution.
Affected count
1,296 packs
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2038-2023

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