Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Quidel Triage Cardiac Panel: REF: 97000HS Recalled by QUIDEL CARDIOVASCULAR INC Due to Raw material issue may cause cardiac panel products...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact QUIDEL CARDIOVASCULAR INC directly.
Affected Products
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
Quantity: 16,194
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 32 states: AL, AK, AZ, CA, CO, FL, GA, HI, IL, IN, IA, KS, LA, MD, MA, MN, MS, MO, MT, NE, NJ, NM, NC, OK, OR, SC, TX, UT, VA, WA, WV, WI
About QUIDEL CARDIOVASCULAR INC
QUIDEL CARDIOVASCULAR INC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report