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U.S. Department of Health and Human Services

Class 2 Device Recall Premier Rotaclone

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 Class 2 Device Recall Premier Rotaclonesee related information
Date Initiated by FirmDecember 01, 2021
Create DateFebruary 02, 2022
Recall Status1 Terminated 3 on February 13, 2023
Recall NumberZ-0552-2022
Recall Event ID 89165
510(K)NumberK852969 
Product Classification Enzyme linked immunoabsorbent assay, rotavirus - Product Code LIQ
ProductPremier Rotaclone, Rx only
Code Information Model Number: RID696004, Lot Number 696004N116, Expiration Date 01/12/2023
FEI Number 1417592
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
866-359-1704
Manufacturer Reason
for Recall		Product stored incorrectly in temperature controlled setting instead of refrigeration.
FDA Determined
Cause 2		Process control
ActionMedline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same.
Quantity in Commerce34 units
DistributionUS Nationwide distribution in the states of California and Massachusetts.
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 = LIQ
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