{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92447",
      "recalling_firm": "QUIDEL CARDIOVASCULAR INC",
      "address_1": "9975 Summers Ridge Rd",
      "address_2": "N/A",
      "postal_code": "92121-2997",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: TX, NC, CA, LA, SC, OR, HI, OK, AZ, AL, KS, WA, FL, VA, IA, WV, MT, UT, CO MS, NM, MA, NJ, MO AK, IL, MN, WI, IN, GA, NE, MD.  OUS: GBR, ITA, FRA, DEU, MCO, EGY, LCA, CHE, ASM, VIR, IRL",
      "recall_number": "Z-1974-2023",
      "product_description": "Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.",
      "product_quantity": "16,194",
      "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.",
      "recall_initiation_date": "20230525",
      "center_classification_date": "20230706",
      "report_date": "20230712",
      "code_info": "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), T13943RN(2023-10-10);   97000HSEU/30014613337928/T13668RBN(2023-07-05), T13705RN(2023-07-14), T13765RBN(2023-08-26), T13825RBN(2023-08-27), T13828RBN(2023-09-18), T13946RBN(2023-10-16);   97000HSEUJP/T13668RN(2023-07-05), T13765RN(2023-08-26), T13828RN(2023-09-18), T13946RN(2023-10-16);   97000HZ01/T13763(2023-08-19), T13764(2023-08-21), T13830(2023-09-24), T13831(2023-09-26), T13940(2023-10-01), T13941(2023-10-03), T13947(2023-10-21), T13951(2023-10-27), T14021(2023-11-06), T14022(2023-11-10), T14024(2023-11-15), T14025(2023-11-19), T14041(2023-12-13), T14042(2023-12-18), T14043(2023-12-19), T14044(2023-12-20), T14045(2023-12-24);   97000QIL/T13825RNQ(2023-08-27).  97000HS/97021HS/97022HS:Any of the lots listed may be assigned to any of the item numbers listed. T13831N, T13831RBN, T13831RN(2023-09-26); T14021N, T14021RBN, T14021RN(2023-11-06); T14022N, T14022RBN, T14022RN(2023-11-10); T14024N, T14024RNB, T14024RN(2023-11-15); T14025N, T14025RBN, T14025RN(2023-11-19); T14041N, T14041RBN, T14041RN(2023-12-13); T14042N, T14042RBN, T14042RN(2023-12-18); T14043N, T14043RBN, T14043RN(2023-12-19); T14044N, T14044RBN, T14044RN(2023-12-20); T14045N, T14045RBN, T14045RN(2023-12-24).  97000HS/97000HSEU/97000QIL/97021HS: Any of the lots listed may be assigned to any of the item numbers listed. T13831N, T13831RBN, T13831RN, T13831NQ, T13831RBNQ, T13831RNQ(2023-09-26); T14021N, T14021RBN, T14021RN, T14021NQ, T14021RBNQ, T14021RNQ(2023-11-06); T14022N, T14022RBN, T14022RN, T14022NQ, T14022RBNQ, T14022RNQ(2023-11-10); T14024N, T14024RNB, T14024RN, T14024NQ, T14024RNBQ, T14024RNQ(2023-11-15); T14025N, T14025RBN, T14025RN, T14025NQ, T14025RBNQ, T14025RNQ(2023-11-19); T14041N, T14041RBN, T14041RN, T14041NQ, T14041RBNQ, T14041RNQ(2023-12-13); T14042N, T14042RBN, T14042RN, T14042NQ, T14042RBNQ, T14042RNQ(2023-12-18); T14043N, T14043RBN, T14043RN, T14043NQ, T14043RBNQ, T14043RNQ(2023-12-19); T14044N, T14044RBN, T14044RN, T14044NQ, T14044RBNQ, T14044RNQ(2023-12-20); T14045N, T14045RBN, T14045RN, T14045NQ, T14045RBNQ, T14045RNQ(2023-12-24).  97000HSEU/97000HSEUJP: Any of the lots listed may be assigned to any of the item numbers listed. T13831N, T13831RBN, T13831RN(2023-09-26); T14021N, T14021RBN, T14021RN(2023-11-06); T14022N, T14022RBN, T14022RN(2023-11-10);  T14024N, T14024RNB, T14024RN(2023-11-15); T14025N, T14025RBN, T14025RN(2023-11-19); T14041N, T14041RBN, T14041RN(2023-12-13); T14042N, T14042RBN, T14042RN(2023-12-18); T14043N, T14043RBN, T14043RN(2023-12-19); T14044N, T14044RBN, T14044RN(2023-12-20); T14045N, T14045RBN, T14045RN(2023-12-24)."
    }
  ]
}