FDA recall Z-2038-2023

Product

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.

Reason for recall

The test medium may not perform as intended.

Distribution

Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution.

Key facts

Status

Ongoing

Initiation date

2023-05-31

Report date

2023-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenexa, KS, United States

Primary source

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