Cardinal Health Recalls Strep B Carrot Broth Due to Temperature Abuse
Cardinal Health is recalling Strep B Carrot Broth One-Step tubes because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.
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 3/5 (High).
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: The recall involves a risk-of-harm product (medical device) where misdiagnosis is a potential consequence, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Cardinal Health Inc. is recalling Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml (Item code Z46BX). This medical device is intended to detect Group B Streptococcus (GBS) from anovaginal specimens collected from pregnant women. The recall covers all lots of the product.
The recall was initiated because three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. The use of these temperature-abused products may result in the misdiagnosis of the patient.
The affected products were distributed nationwide in the United States, specifically in North Carolina, Kansas, and Alabama. Healthcare providers and patients should stop using the recalled products and contact Cardinal Health Inc. for further instructions.
The recalled product
- Product
- Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment…
- Manufacturer
- Cardinal Health Inc.
- Category
- Medical Device — Laboratory Test
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 (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 3 recalled by Cardinal Health 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.
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