Z-2051-2020Class II

Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX -

Name: Z-2051-2020 Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX -
Creator: Cardinal Health Inc.
Published: 2020-04-20
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-04-20 / Terminated

FDA source

Cardinal Health Inc. began a recall of Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen... on 2020-04-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2051-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-20
Posted: 2020-05-20
Terminated: 2020-07-23
Recalling firm: Medtronic, Inc.
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.
Product code: PQZ Gbs Culture Media, Selective And Differential
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 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 ([email protected]) 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.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2051-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2049-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-20
Z-2050-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-20
Z-2051-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-20

Product code PQZ

K170586Class IStrep B Carrot Broth One-StepHardy Diagnostics / cleared 2017-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)