The Recall Desk
ModerateFDA (Devices)·Z-3017-2018·Announced 2018-09-19

Remel Thioglycollate Medium Recalled for Performance Testing Failures

Remel Inc is recalling specific lots of Thioglycollate Medium because the products intermittently failed performance testing during stability studies with anaerobic microorganisms.

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, and the source text describes a performance failure without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Remel Inc is recalling 2,730 units of Remel Thioglycollate Medium W/O IND. W/ Dextrose W/ Hemin & Vit.K. The affected products include 10ml, 5ml, and 9ml vials with specific reference numbers and lot numbers listed in the recall documentation. These products were distributed in the United States, Canada, and Singapore.

The recall was initiated because the products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. This indicates that the medium may not perform as expected when used to culture these specific types of bacteria.

Healthcare facilities and laboratories that have purchased these specific lots should stop using the products and contact Remel Inc for instructions on how to return or dispose of them. Consumers should check their inventory for the specific reference numbers and lot numbers provided in the official recall notice.

The recalled product

Product
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
Manufacturer
Remel Inc
Affected units
2,730

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)

  • (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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →