FDA recall Z-3017-2018

Product

remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720

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-3017-2018