The Recall Desk
ModerateFDA (Devices)·Z-1400-2019·Announced 2019-05-29

Remel Thio Med Culture Media Recalled for Potential Performance Failure

Remel Inc is recalling Thio Med culture media because the product may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a performance failure rather than a direct physical injury or contamination, fitting the Moderate category for a precautionary recall regarding product efficacy.

Plain-English summary

Remel Inc is recalling 2,395 units of Thio Med w/o Ind, w/Dex (9ml) 100/PK culture media. This product is recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes. The recall is due to a potential for the products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after the date of manufacturing.

The affected lots have expiration dates ranging from November 26, 2018, to July 31, 2019. The recall involves a worldwide distribution, including US nationwide to all 50 states, DC, and Puerto Rico, as well as international distribution to Canada.

Users should stop using the affected lots and contact Remel Inc for further instructions. The expiration date for these products is being shortened from 9 months to 105 days to address the potential performance issues.

The recalled product

Product
Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Manufacturer
Remel Inc
Category
Medical Device — Laboratory Reagents
Hazard
Affected units
2,395

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Material Number: R064700
  • Lot Number (Labeled Expiration Date): 298271 (11/26/2018)
  • 314882 (12/24/2018)
  • 316605 (12/26/2018)
  • 318895 (12/31/2018)
  • 323453 (01/08/2019)
  • 326336 (01/14/2019)
  • 327633 (01/15/2019)
  • 328655 (01/16/2019)
  • 329879 (01/17/2019)
  • 332323 (01/23/2019)
  • 335242 (01/29/2019)
  • 337936 (02/05/2019)
  • 339205 (02/06/2019)
  • 345315 (02/19/2019)
  • 346704 (02/27/2019)
  • 353569 (03/06/2019)
  • 359076 (03/18/2019)
  • 360812 (03/20/2019)
  • 363509 (03/26/2019)

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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