FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corporation: The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
- Recall number
- Z-1979-2019
- Recalling firm
- Roche Diagnostics Corporation
- Product
- The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
- Status
- Terminated
- Initiated
- 2019-06-03
- Posted
- not on file
- Terminated
- 2020-08-28
- Reason
- Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
- Root cause
- Material/Component Contamination
- Action
- Urgent Medical Device Correction notification letters dated 6/3/19 were sent to customers.
- Quantity
- 8 units
- Distribution
- The products were distributed to the following US states: AL, IN, and KY.
- Lot, serial or model codes
- Lot 368756
- 510(k) numbers
- ["K040435"]
- PMA numbers
- not on file
- Product code
- CZP
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- 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