Z-3018-2018 Class II Terminated

Recalled by Remel Inc — Lenexa, KS

Recall Details

Product Type
Devices
Report Date
September 19, 2018
Initiation Date
August 13, 2018
Termination Date
June 18, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
384 units

Product Description

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 Pattern

US, Canada, Singapore

Code Information

(a) 9ML, REF 064700, Lot numbers: 254751, 259508, 272498 (b) 10ML, REF 07176, Lot numbers: 259521 (c) 9ML, REF 064702, Lot numbers: 274247