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U.S. Department of Health and Human Services

Class 2 Device Recall Strep B Carrot Broth OneStep

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  Class 2 Device Recall Strep B Carrot Broth OneStep see related information
Date Initiated by Firm April 20, 2020
Create Date May 20, 2020
Recall Status1 Terminated 3 on July 23, 2020
Recall Number Z-2051-2020
Recall Event ID 85509
510(K)Number K170586  
Product Classification GBS culture media, selective and differential - Product Code PQZ
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.
Code Information All lots
Recalling Firm/
Manufacturer		 Cardinal Health Inc.
7000 Cardinal Pl
Dublin OH 43017-1091
For Additional Information Contact Customer Service Group
888-444-5440
Manufacturer 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.
FDA Determined
Cause 2		 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@cardinalhealth.com) and indicate the product code, lot and quantity of product youve quarantined or discarded. Please respond regardless of whether or not you have affected product. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday  Friday between 8:00am - 5:00pm EST: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other Customers888-444-5440
Distribution US Nationwide distribution NC, KS, and AL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PQZ and Original Applicant = Hardy Diagnostics
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