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U.S. Department of Health and Human Services

Class 2 Device Recall Biotrin Parvovirus B19 IgG Enzyme Immunoassay

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 Class 2 Device Recall Biotrin Parvovirus B19 IgG Enzyme Immunoassaysee related information
Date Initiated by FirmJuly 17, 2020
Create DateSeptember 03, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2936-2020
Recall Event ID 86152
PMA NumberP970054 
Product Classification Assay,enzyme linked immunosorbent,parvovirus b19 igg - Product Code MYL
ProductParvovirus B19 IgG EIA kit Part No. V519IGUS
Code Information Lot 71440040AA
FEI Number 2182595
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
Manufacturer Reason
for Recall		Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
FDA Determined
Cause 2		Under Investigation by firm
ActionDiaSorin issued a customer notification letter on July 17, 2020. The letter states the following action to be taken: Please use the Lot Specific Constant value of 0.14 with your remaining inventory of Lot 71440040AA.. The Lot Specific Constant is used to calculate the cut-off value and use of the incorrect value may lead to: 1. An invalid test due to the Low Positive Control resulting above the upper limit of the assigned range. 2. The reporting of a false positive patient result if the Low Positive Control does not fail and invalidate the test run. If you have used the affected product Lot 71440040AA in combination with the incorrect Lot Specific Constant of 0.10 and you obtained valid runs, please: 1. Review the test results of these valid runs for values between 1.1 Index and 1.54 Index, which may have been falsely reported as positive. 2. Take actions as appropriate. 3. DiaSorin recommends discussing the content of this letter with your laboratory director with respect to the need to review previous test results, conduct patient follow-up and/or repeat testing as appropriate. Complete page two of this letter and return to DiaSorin Inc. Forward this letter to anyone in your organization who may be impacted. We apologize for any inconvenience this may cause. If you have any questions regarding this notice please contact DiaSorin Inc. Technical Support at 1-800-328-1482.
Quantity in Commerce615 units
DistributionNJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT Canada
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MYL
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