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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Rapid Dx N America LLC McKesson Consult" hCG Urine Controls

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  Class 2 Device Recall Abbott Rapid Dx N America LLC McKesson Consult" hCG Urine Controls see related information
Date Initiated by Firm January 09, 2024
Date Posted March 19, 2024
Recall Status1 Open3, Classified
Recall Number Z-1312-2024
Recall Event ID 94024
510(K)Number K050328  
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
Product Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
Code Information Catalogue Number: 5011; UDI/DI: 612479202788; Lot No. KN00589;
Recalling Firm/
Manufacturer		 Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233
For Additional Information Contact Randy King
804-553-2281
Manufacturer Reason
for Recall		 Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
FDA Determined
Cause 2		 Storage
Action McKesson notified customers by phone January 9, 2024 with a follow-up call January 17, 2024 instructing customers of three scenarios based upon the products they received and the investigation in conjunction with relevant manufacturer. The firm also sent Urgent Product Recall Notifications via email on February 8, 2024 instructing customers to immediately examine inventory and quarantine all affected devices, complete and return the provided response form to MMSQRCProductReviews@Mckesson.com, and notify customers who you have further distributed recalled devices to of this recall and to segregate and quarantine any devices they have on hand. Replacement products will be provided and may have the same lot number(s) as the recalled items but are not affected by the recall and are acceptable for use. Customers with questions can contact McKesson directly by phone at (800) 688-8840. Representatives are available Monday to Friday, 8:00 am to 5:00 pm PST.
Quantity in Commerce 3 units
Distribution US Nationwide distribution in the states of AZ, PA and TX.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JJX and Original Applicant = BIOCHEMICAL DIAGNOSTIC, INC.
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