Remel Inc: Medical Device Recall in 2018 - (Recall #: Z-3018-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 13, 2018

Date Posted: September 19, 2018

Recall Number: Z-3018-2018

Event ID: 80813

Reason for Recall:

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

Status: Terminated

Product Quantity: 384 units

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

Distribution Pattern:

US, Canada, Singapore

Voluntary or Mandated:

Voluntary: Firm initiated