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U.S. Department of Health and Human Services

Class 2 Device Recall Acceava Respiratory Strep A

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 Class 2 Device Recall Acceava Respiratory Strep Asee related information
Date Initiated by FirmAugust 20, 2024
Date PostedSeptember 19, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3185-2024
Recall Event ID 95235
510(K)NumberK010582 
Product Classification Antigens, all groups, streptococcus spp. - Product Code GTY
ProductAcceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Code Information GTIN: 10815845020031; All Lots
Recalling Firm/
Manufacturer		 Cypress Medical Products LLC
9954 Mayland Dr
Richmond VA 23233-1464
For Additional Information ContactRandy King
804-553-2068
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionAn 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 MMSQRCProductReviews@McKesson.com. 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 Commerce5 kits
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GTY
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