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U.S. Department of Health and Human Services

Class 2 Device Recall The Quidel Triage BNP Calibrators

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 Class 2 Device Recall The Quidel Triage BNP Calibratorssee related information
Date Initiated by FirmOctober 01, 2020
Create DateOctober 26, 2020
Recall Status1 Terminated 3 on May 03, 2021
Recall NumberZ-0297-2021
Recall Event ID 86560
510(K)NumberK033383 
Product Classification Test, natriuretic peptide - Product Code NBC
ProductThe Quidel Triage BNP Calibrators
Code Information Model Number: ALR98202  Expiration date:  Lot 832243, exp date 12/31/19 Lot 832570, exp date 03/31/20 Lot 921292, exp date 08/31/20 Lot 921565, exp date 12/31/20 Lot 921836, exp date 02/28/21  Lot 922069, exp date 03/31/21 
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		Product compromised during shipment.
FDA Determined
Cause 2		Process control
ActionOn Oct 1st 2020, the firm sent a letter to its consignees with the following instructions: 1. Immediately check your stock for the affected item number and lots, listed on the attached destruction form. Quarantine all affected product. 2. Please return the completed enclosed destruction form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. Your account will receive credit when the destruction form is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication.
Quantity in Commerce26 devices
DistributionDomestic Distribution only to: CA, NY, TX and VA
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 = NBC
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