Remel Inc recalls remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF…

Recall date

August 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3017-2018

FDA classification

Class II

Brand / firm

Remel Inc

Sold / distributed

US, Canada, Singapore

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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