Z-2936-2020Class II

Parvovirus B19 IgG EIA kit Part No. V519IGUS

Name: Z-2936-2020 Parvovirus B19 IgG EIA kit Part No. V519IGUS
Creator: Diasorin Inc.
Published: 2020-07-17
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2020-07-17 / Open, Classified / root cause: labeling and UDI

FDA source

Diasorin Inc. began a recall of Parvovirus B19 IgG EIA kit Part No. V519IGUS on 2020-07-17. FDA classified it as Class II and gives the reason as "Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2936-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-17
Posted: 2020-09-03
Recalling firm: Diasorin Inc.
Product: Parvovirus B19 IgG EIA kit Part No. V519IGUS
Product code: MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
Reason for recall: Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: DiaSorin 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 commerce: 615 units
Distribution: NJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT Canada
Product codes and lots: Lot 71440040AA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2936-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2936-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-09	2020-09-03

Product code MYL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)