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U.S. Department of Health and Human Services

Class 2 Device Recall Clearview Strep A Exact II Dipstick Respiratory Kit

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 Class 2 Device Recall Clearview Strep A Exact II Dipstick Respiratory Kitsee related information
Date Initiated by FirmJuly 30, 2025
Date PostedAugust 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2337-2025
Recall Event ID 97315
510(K)NumberK010582 
Product Classification Antigens, all groups, streptococcus spp. - Product Code GTY
ProductClearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Code Information Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
Recalling Firm/
Manufacturer		 Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233
For Additional Information ContactAlexia Allina
984-292-4539
Manufacturer Reason
for Recall		Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
FDA Determined
Cause 2		Process control
ActionMcKesson notified consignees on about 07/30/2025 via overnight mail. Consignees were instructed to immediately examine inventory and quarantine all affected units, complete and return the provided response form, and destroy any affected products. If affected product was further distributed, consignees were instructed to notify their customers.
Quantity in Commerce5 kits
DistributionUS Nationwide distribution in the state of Georgia.
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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