Recall Z-2051-2020 ยท PQZ Gbs Culture Media, Selective And Differential
Cardinal Health Inc.
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.
| Date | Apr 20, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Storage |
| Action | On April 20, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that the product had been incorrectly stored and that there was a potential for misdiagnosis. Action Required: 1. CHECK all storage and usage locations to confirm whether you have any units of the affected product codes and lot numbers containing the labeling outlined in the letter. 2. SEGREGATE and QUARANTINE all on-hand affected product. 3. PLEASE RETURN the letter's acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email (GMB-FieldCorrectiveAction@ca |
| Distribution | US Nationwide distribution NC, KS, and AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170586 | Strep B Carrot Broth One-Step Hardy Diagnostics, May 22, 2017 |