FDA recall Z-2137-2018

Product

remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

Reason for recall

Product may fail performance testing for S aureus ATCC 43300.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2018-05-04

Report date

2018-06-20

Termination date

2018-12-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2137-2018