Strep B Carrot Broth One-Step — Class II medical device recall Z-2051-2020
Terminated recall by Cardinal Health Inc., reported 2020-05-27, distributed nationwide. Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperatu
| Recall number | Z-2051-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2020-04-20 |
| Classified | 2020-05-20 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2020-07-23 |
| Distributed | Nationwide (US) |
| Reason classes | temperature control |
| Model numbers | Z46BX |
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 prior to vaginal delivery in order to prevent infection of the neonate.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2051-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.