The Recall Desk
ModerateFDA (Devices)·Z-1405-2019·Announced 2019-05-29

Remel Thio Med Media Recalled for Potential Performance Failure

Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is 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: This is a Class II recall involving a performance defect in a laboratory media product. There are no reports of injury or illness, and the hazard is limited to potential test failure rather than direct physical harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Remel Inc is recalling 248 units of Thio Med w/o Ind, w/Dex (10ml) 100/PK. This product is a general purpose media recommended for use in qualitative procedures 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. As a result, the expiration date is shortened from 9 months to 105 days.

The affected lots include Material Number R07176 and R8850 with various lot numbers and expiration dates ranging from December 2018 to August 2019. The products were distributed nationwide in the United States, to Puerto Rico, and internationally to Canada. Users should check their inventory for the specific lot numbers listed in the recall notice and discontinue use of any affected units.

The recalled product

Product
Thio Med w/o Ind, w/Dex (10ml) 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 Media
Hazard
Affected units
248

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 (13)

  • Material Number: R07176
  • Lot Number (Labeled Expiration Date): 309154 (12/12/2018)
  • 328732 (01/16/2019)
  • 340307 (02/07/2019)
  • 362767 (03/25/2019)
  • 366061 (03/28/2019)
  • 386121 (05/08/2019)
  • 392563 (05/21/2019)
  • Lot Number (Labeled Expiration Date): 329867 (01/17/2019)
  • 354771 (03/07/2019)
  • 377024 (04/22/2019)
  • 394853 (05/23/2019)
  • 417667 (07/16/2019).

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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