Roche recalls Tina-quant lgA Gen. 2 blood tests due to calibration failures from reagent contamination. Affected lots include 368756. Stop using if you have this test kit.
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.
Roche is recalling its Tina-quant lgA Gen.2 blood test kits because contamination between reagents can cause calibration errors. This may lead to inaccurate test results if used without proper calibration.
Contamination between reagents (R1 and R3) can cause calibration failures in the test. This leads to errors in the test results, potentially giving inaccurate readings for lgA antibodies.
People who use the Tina-quant lgA Gen.2 blood test kits with lot number 368756 are affected. Those who rely on accurate test results for health monitoring are at higher risk.
Check the lot number on the test kit. The affected lot is 368756. This product is sold by Roche Diagnostics Corporation.
Look for the lot number on the test kit. The affected lot is 368756.
The Tina-quant lgA Gen.2 test kits have experienced calibration failures due to contamination between reagents, which can cause inaccurate test results.
Check the lot number on the test kit. If it is 368756, stop using it and contact Roche for further instructions.
No, the recall is for inaccurate test results, not physical injury. The hazard is low risk as it does not cause direct harm.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1979-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-1979-2019 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
