Z-3184-2024Class II

BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

Name: Z-3184-2024 BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Creator: Cypress Medical Products LLC
Published: 2024-08-20
License: https://open.fda.gov/license/

Cypress Medical Products LLC / initiated 2024-08-20 / Open, Classified / root cause: manufacturing process

FDA source

Cypress Medical Products LLC began a recall of BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 on 2024-08-20. FDA classified it as Class II and gives the reason as "Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3184-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-20
Posted: 2024-09-19
Recalling firm: Cypress Medical Products LLC
Product: BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Product code: GTZ Antisera, All Groups, Streptococcus Spp.
Reason for recall: Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT PRODUCT RECALL notification letter dated 8/19/24 was sent to customers. Actions to be taken by the customer 1. Immediately examine your inventory and quarantine all product subject to this urgent product recall detailed in the affected products table above. 2. Please complete, sign, and return the enclosed response form (Attachment #1 Customer Response Form) as soon as possible, even if you do not have any product on hand. Return completed signed form to [email protected]. 3. Destroy any affected product and complete the attached customer response form (Attachment #1 Costumer Response Form). If you have any questions, you can call directly by phone at (800) 688-8840. Representatives are available Monday Friday, 8:00 am 5:00 pm. 4. If you have further distributed this product, please notify them immediately of this urgent product recall. You are encouraged to include a copy of this notification letter in your communication. If you have questions regarding this notification, please contact McKesson Medical- Surgical directly by phone at (800) 688-8840. Representatives are available Monday Friday, 8:00 am 5:00 pm.
Quantity in commerce: 15 kits
Distribution: US Nationwide distribution.
Product codes and lots: GTIN: 10811877010453; All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3184-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3184-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3185-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19

Product code GTZ

K012521Class IBinax Now Streptococcus Pneumoniae TestBinax, Inc. / cleared 2001-11-30

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)