The Recall Desk
HighFDA (Devices)·Z-2531-2023·Announced 2023-09-20

Remel Todd Hewitt Broth Culture Medium May Fail to Detect Target Organism

One lot of Remel Todd Hewitt Broth culture medium may fail to recover Group B Streptococci during testing or use with patient samples, potentially resulting in missed diagnoses.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a diagnostic reagent that may fail to detect Group B Streptococci in patient samples, representing a risk of missed diagnoses. The source contains no reports of illnesses or injuries.

Plain-English summary

Remel, Inc. is recalling lot 668255 (expiration 04/26/2024) of its Todd Hewitt Broth with CNA (LIM), a culture medium used in clinical laboratories to isolate Group B Streptococci from mixed bacterial samples. The recall encompasses 139 units (13,900 tests) that were distributed nationwide in the United States.

The affected lot may fail to recover Group B Streptococci during routine quality control testing or when processing patient clinical samples. This diagnostic failure could result in the organism not being detected when present in a sample.

This product is used exclusively in laboratory and clinical diagnostic settings.

The recalled product

Product
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Manufacturer
Remel, Inc
Category
Medical Device — Diagnostic Reagent / Culture Medium
Hazard

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 (3)

  • UDI/DI 00848838010064
  • lot 668255
  • Exp. 04/26/2024

Distribution

Distributed nationwide across the United States.

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