QUIDEL CARDIOVASCULAR INC: Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.

Hazard

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.

Details from the source

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. Distribution: 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 Quantity: 16,194 Lot/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);

UPC codes

30014613337911, 30014613337935, 30014613337942, 30014613337928

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.