Cardinal Health recalls Strep B Carrot Broth One-Step tubes due to potential misdiagnosis from improper refrigeration. Affected pregnant women may receive incorrect GBS test results.
Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Cardinal Health is recalling Strep B Carrot Broth One-Step test tubes because they were stored outside the required temperature range. This could lead to incorrect results for Group B Streptococcus (GBS) testing in pregnant women, potentially affecting delivery decisions.
The test tubes require refrigeration but were stored outside approved temperature ranges. This can cause the product to become unstable, leading to potential misdiagnosis of Group B Streptococcus in pregnant women.
Pregnant women using this test for Group B Streptococcus detection may receive incorrect results if the product was stored improperly. The risk is highest for those who have already used the product.
Check for the Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml with item code Z46BX. This product was sold for detecting Group B Streptococcus in pregnant women.
Verify if the product was stored outside the required temperature range before use.
The product may have been misdiagnosed if stored improperly, so check storage conditions before use.
Improper storage can cause the product to become unstable, leading to potential misdiagnosis of Group B Streptococcus.
The recall does not provide a remedy, so users should check storage conditions and contact the manufacturer if concerns exist.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-2051-2020 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-2051-2020 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
