Remel Inc: Medical Device Recall in 2018 - (Recall #: Z-3017-2018)

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 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

Product Classification:

Class II

Date Initiated: August 13, 2018

Date Posted: September 19, 2018

Recall Number: Z-3017-2018

Event ID: 80813

Reason for Recall:

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

Status: Terminated

Product Quantity: 2730 units

Code Information:

(a) 10ML, REF 07182, Lot numbers: 258907, 260413, 258908, 260519 (b) 10ML, REF 07180, Lot numbers: 259526, 258906, 258903, 258904, 258905 (c) 5ML, REF 064732, Lot numbers: 271667, 258182, 259521 (d) 5ML, REF 064730, Lot numbers: 254755, 272020, 260509, 258181, 273564, 258627, 271476, 258629, 271665, 259507, 251146, 272499 (e) 9ML, REF 064720, Lot numbers: 254749, 272497, 251145, 272015, 258183, 258626, 271479, 258625

Distribution Pattern:

US, Canada, Singapore

Voluntary or Mandated:

Voluntary: Firm initiated