Quidel Triage Cardiac Panel Affected by Troponin Signal Reduction Defect
Quidel Triage Cardiac Panel diagnostic kits are recalled due to a raw material defect causing approximately 30% troponin signal reduction. The defect won't be detected by quality controls, potentially resulting in missed or delayed heart attack diagnosis.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class I recall from the FDA, which establishes a minimum severity score of 4. The defect creates substantial risk of patient harm—specifically, missed or delayed heart attack diagnosis due to reduced troponin signal undetected by quality control testing. No illnesses or deaths have been reported.
Plain-English summary
The Quidel Triage Cardiac Panel diagnostic test kits (reference numbers 97000HS, 97021HS, 97022HS, 97000HSEU, 97000HSEUJP, 97000HZ01, and 97000QIL) are subject to recall. A raw material defect affects 16,194 units distributed across the United States and internationally. The affected lot numbers range from T13664 through T14045.
A raw material issue causes an average 30% reduction in troponin signal across the measurement range of 0.05 ng/mL to 30 ng/mL. Troponin is a key cardiac biomarker used to detect myocardial infarction (heart attack). The signal reduction will not be detected by the device's standard quality control testing, which means affected kits may provide inaccurately low troponin readings.
Healthcare providers using affected Quidel Triage Cardiac Panel kits should discontinue use and switch to alternative testing methods. If alternative methods are not available, the FDA recommends implementing mitigation measures to reduce potential patient impact. The primary risk is missed or delayed diagnosis of myocardial infarction due to underreported troponin levels.
The recalled product
- Product
- Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
- Manufacturer
- QUIDEL CARDIOVASCULAR INC
- Affected units
- 16,194
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Lots(Expiration): 97000HS/30014613337911/T13666N(2023-06-26)
- T13667N(2023-07-03)
- T13669N(2023-07-08)
- T13706N(2023-07-21)
- T13826N(2023-09-03)
- T13944N(2023-10-14)
- T13948N(2023-10-20)
- T13949N(2023-10-22)
- T14019N(2023-11-05)
- T14020N(2023-11-05)
- T14023N(2023-11-11)
- 97021HS/30014613337935/T13665RN(2023-06-25)
- T13707RN(2023-06-28)
- T13709RN(2023-08-11)
- T13827RN(2023-09-04)
- T13829RN(2023-09-18)
- T13942RN(2023-10-09)
- T13950RN(2023-10-23)
- 97022HS/30014613337942/T13664RN(2023-06-20)
- T13708RN(2023-08-03)
Distribution
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