Acceava Respiratory Strep A, CLIA Waived, Catalog Number… recallZ-3185-2024 · Cypress Medical Products LLC · initiated Aug 20, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cypress Medical Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-3185-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 20, 2024
- Posted by the FDA
- Sep 19, 2024
- Recalling firm
- Cypress Medical Products LLC
- Quantity
- 5 kits
- Product code
- GTY
- FDA submissions
- K010582
- Distribution
- US Nationwide distribution.
Product description
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Code information (models, lots, serial numbers)
GTIN: 10815845020031; All Lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Acceava® 92001Alere San Diego, Inc. · Antigens, All Groups, Streptococcus Spp.2 recalls2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95235).
- Z-3184-2024 · Open, ClassifiedBinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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