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U.S. Department of Health and Human Services

Class 2 Device Recall Triage Total Calibration Verification 5

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  Class 2 Device Recall Triage Total Calibration Verification 5 see related information
Date Initiated by Firm July 28, 2020
Create Date September 30, 2020
Recall Status1 Terminated 3 on February 13, 2023
Recall Number Z-3054-2020
Recall Event ID 86258
510(K)Number K072892  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Control, Calibrator Verified, Triage BNP, Model ALR88755
Code Information Lot Number and/or Serial Number: 30718, 407522, 420694, 422646, 430000, 422647N, 422648N, 428255N,428256N, 441421N, 441422N, 441423N
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 Product was shipped with refrigeration (ice) instead of frozen (dry ice).
FDA Determined
Cause 2		 Process control
Action Medline Industries sent formal letters with response forms to affected consignees via 1st class mail on August 3, 2020. Customers were asked to initiate sub-recalls where appropriate. Consignees were provided with a destruction form to return via fax or email. Each destruction form received with be recorded and Medline Industries, Inc. will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. Consignees are asked to confirm the destruction of any affected product on hand.
Quantity in Commerce 118 units
Distribution Distribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJY and Original Applicant = BIOSITE INCORPORATED
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