Recall Z-2051-2020— Cardinal Health Inc.
Class II · Terminated
Class II FDA medical device recall by Cardinal Health Inc., initiated 2020-04-20, terminated 2020-07-23. It names one FDA 510(k) clearance: K170586. 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: 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..
- Recalling firm
- Cardinal Health Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-20
- Terminated
- 2020-07-23
- Firm location
- Dublin, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.