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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 5see related information
Date Initiated by FirmJuly 28, 2020
Create DateSeptember 30, 2020
Recall Status1 Terminated 3 on February 13, 2023
Recall NumberZ-3054-2020
Recall Event ID 86258
510(K)NumberK072892 
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductControl, 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
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information ContactKassandra 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
ActionMedline 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 Commerce118 units
DistributionDistribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, TX
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJY
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