FDA Medical Device Recalls (openFDA)
Diasorin Inc.: Parvovirus B19 IgG EIA kit Part No. V519IGUS
- Recall number
- Z-2936-2020
- Recalling firm
- Diasorin Inc.
- Product
- Parvovirus B19 IgG EIA kit Part No. V519IGUS
- Status
- Open, Classified
- Initiated
- 2020-07-17
- Posted
- not on file
- Terminated
- not on file
- Reason
- Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
- 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
- 615 units
- Distribution
- NJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT Canada
- Lot, serial or model codes
- Lot 71440040AA
- 510(k) numbers
- not on file
- PMA numbers
- ["P970054"]
- Product code
- MYL
- Firm FEI
- 2182595
- Firm city
- Stillwater
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28