Quidel recalls specific cardiac panel products due to raw material issues causing 30% troponin signal reduction, potentially leading to missed heart attacks. QC tests don't detect the problem, so alternate methods are needed.
Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternate method is recommended, if unavailable, use recommendations to mitigate potential patient impact, which could be missed/delayed myocardial infarction diagnosis.
Quidel is recalling certain cardiac test kits because a raw material issue causes them to show 30% lower troponin levels than expected. This could lead to missed heart attack diagnoses if not corrected. Patients using these kits should check their product codes and follow the recommended steps.
The raw material issue causes the cardiac panels to show 30% lower troponin levels across a specific measurement range. This means the test might not detect heart attacks properly, especially if the patient's troponin levels are low. Quality control tests don't catch this problem, so the issue could go unnoticed.
Healthcare providers using the recalled Quidel Triage Cardiac Panel kits for cardiac tests are most at risk. Patients using these kits for heart-related testing may experience delayed diagnosis if the test is inaccurate.
Check the product code on the kit (e.g., 97000HS, 97021HS, 97022HS, 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL). Look for the lot numbers listed in the recall notice, which include specific expiration dates and serial codes.
Identify the product code on the kit (e.g., 97000HS, 97021HS, 97022HS, 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL).
Reach out to Quidel for guidance on whether the kit is affected and what steps to take next.
A raw material issue causes the panels to show 30% lower troponin levels across the measurement range 0.05 ng/mL to 30 ng/mL, which could lead to missed heart attacks if not corrected.
Check the product code and lot number on the kit. Affected kits have specific codes like 97000HS, 97021HS, 97022HS, 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL, with lot numbers listed in the recall notice.
No, but you should check if your kit is affected and contact Quidel for guidance. The recall does not require immediate discontinuation but recommends verification and alternative methods.
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-1974-2023 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-1974-2023 from Quidel. 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.
