Quidel Triage Cardiac Panel: REF: 97000HS — Class I medical device recall Z-1974-2023
Ongoing recall by QUIDEL CARDIOVASCULAR INC, reported 2023-07-12, distributed in AK, AL, AZ, CA, CO, FL, GA, HI…. Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across
| Recall number | Z-1974-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | QUIDEL CARDIOVASCULAR INC, San Diego, CA, United States |
| Recall initiated | 2023-05-25 |
| Classified | 2023-07-06 |
| Reported by FDA | 2023-07-12 |
| Distributed | AK, AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NC, NE, NJ, NM, OK, OR, SC, TX, UT, VA, WA, WI, WV |
| Quantity | 16,194 |
| UPC / GTIN / UDI-DI | 30014613337911, 30014613337928, 30014613337935, 30014613337942 |
| Lot numbers | T13664, T14045 |
| Model numbers | 97000HS, 97021HS |
Product
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1974-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.