The Tina-quant lgA Gen.2 is an immunoturbidimetric recall: Contamination
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…
Why was The Tina-quant lgA Gen.2 is an immunoturbidimetric recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 368756
- 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…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 8 units
- Distribution
- The products were distributed to the following US states: AL, IN, and KY.
- Recall date
- July 24, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)