Z-3018-2018Class II

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

Name: Z-3018-2018 remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF...
Creator: Remel Inc
Published: 2018-08-13
License: https://open.fda.gov/license/

Remel Inc / initiated 2018-08-13 / Terminated

FDA source

Remel Inc began a recall of remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702 on 2018-08-13. FDA classified it as Class II and gives the reason as "Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3018-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-13
Posted: 2018-09-07
Terminated: 2019-06-18
Recalling firm: Remel Inc
Product: remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
Product code: JSG Culture Media, Non-Selective And Non-Differential
Reason for recall: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
FDA root cause: Under Investigation by firm
Action: The firm initiated the recall by letter on 08/13/2018. The firm directed the consignee to you inspect their stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. They also requested that the consignee review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action. The firm instructed the consignee to further distribute the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For questions, please contact Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in commerce: 384 units
Distribution: US, Canada, Singapore
Product codes and lots: (a) 9ML, REF 064700, Lot numbers: 254751, 259508, 272498 (b) 10ML, REF 07176, Lot numbers: 259521 (c) 9ML, REF 064702, Lot numbers: 274247

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3018-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3017-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-07
Z-3018-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-07
Z-3019-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-07

Product code JSG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)