FDA recall Z-3018-2018

Product

remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702

Reason for recall

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

Distribution

US, Canada, Singapore

Key facts

Status

Terminated

Initiation date

2018-08-13

Report date

2018-09-19

Termination date

2019-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3018-2018