The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1401-2019·Announced 2019-05-29

Remel Thio Med w/Dex, Hem, Vit K Media Recall for Performance Failure

Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because products may fail performance testing after 106 days from manufacturing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 corresponds to a moderate severity score. The hazard is a potential failure of performance testing (quality control issue) rather than a direct physical injury or high-risk pathogen exposure, and no illnesses or injuries are reported in the source text.

Plain-English summary

Remel Inc is recalling 2,263 units of Thio Med w/Dex, Hem, Vit K (9ml) 100/PK. This product is a general-purpose media recommended for qualitative procedures to cultivate aerobes and anaerobes. The recall was initiated because the products have the potential to fail performance testing according to the Instructions for Use (IFU) starting at 106 days after the date of manufacturing. As a result, the expiration date for these products is being shortened from 9 months to 105 days.

The affected products were distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico. International distribution was limited to Canada. The recall includes specific lot numbers with expiration dates ranging from November 27, 2018, to July 17, 2019. The material number for the affected product is R064720.

Users of this product should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Remel Inc or the distributor in accordance with the recall instructions. This action ensures that only media within the verified 105-day stability window is used for laboratory procedures.

The recalled product

Product
Thio Med w/Dex, Hem, Vit K (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 Media
Hazard
Affected units
2,263

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: R064720
  • Lot Number (Labeled Expiration Date): 298486 (11/27/2018)
  • 309147 (12/12/2018)
  • 313760 (12/20/2018)
  • 314883 (12/24/2018)
  • 316606 (12/26/2018)
  • 320904 (01/01/2019)
  • 325887 (01/10/2019)
  • 329880 (01/17/2019)
  • 337679 (02/04/2019)
  • 340776 (02/11/2019)
  • 342665 (02/13/2019)
  • 347320 (02/28/2019)
  • 354828 (03/07/2019)
  • 358178 (03/14/2019)
  • 359886 (03/19/2019)
  • 363510 (03/26/2019)
  • 367408 (04/02/2019)
  • 369555 (04/08/2019)
  • 372099 (04/11/2019)

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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