Quidel Triage Cardiac Panel recall
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots…
Why was Quidel Triage Cardiac Panel 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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).
- Product
- Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots…
- Recalling firm
- QUIDEL CARDIOVASCULAR INC
- Quantity
- 16,194
- 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
- Recall date
- July 12, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)