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U.S. Department of Health and Human Services

Class 2 Device Recall TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES

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 Class 2 Device Recall TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTESsee related information
Date Initiated by FirmApril 24, 2025
Date PostedMay 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1826-2025
Recall Event ID 96752
Product Classification Colorimetric method, triglycerides - Product Code JGY
ProductABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
Code Information Catalog No. 97991; GTIN: 893038002937; Order No. 46102674.
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		transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
FDA Determined
Cause 2		Storage
ActionAn URGENT PRODUCT RECALL notification dated 4/21/25 was mailed to consignees. The notification instructs consignees to immediately examine their inventory and quarantine all product identified as subject to this recall action. Consignees are asked to return the completed response form to MMSQARecalls@McKesson.com and to destroy any quarantined devices. Questions about this recall can be directed to 1-800-688-8840 from 8:00 am to 5:00 pm Monday through Friday. If product has been further distributed, consignees are asked to forward the provided recall notice to those customers.
Quantity in Commerce50 units
DistributionUS Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
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.
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