Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to d...
FDA Device Recall #Z-2051-2020 — Class II — April 20, 2020
Recall Summary
| Recall Number | Z-2051-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 20, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cardinal Health Inc. |
| Location | Dublin, OH |
| Product Type | Devices |
| Quantity | N/A |
Product Description
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.
Distribution Pattern
US Nationwide distribution NC, KS, and AL.
Lot / Code Information
All lots
Other Recalls from Cardinal Health Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1934-2021 | Class II | DEXCOM G6 SENSOR 3 PACK Item Number: 5447552 | Mar 16, 2021 |
| Z-1937-2021 | Class II | ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Numb... | Mar 16, 2021 |
| Z-1930-2021 | Class II | FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTE... | Mar 16, 2021 |
| Z-1941-2021 | Class II | OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Ite... | Mar 16, 2021 |
| Z-1942-2021 | Class II | ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Numbe... | Mar 16, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.