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.

Recall number

Z-1974-2023

Recalling firm

QUIDEL CARDIOVASCULAR INC

Product

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

Status

Open, Classified

Initiated

2023-05-25

Posted

2023-07-07

Terminated

not on file

Reason

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.

Root cause

Nonconforming Material/Component

Action

On 5/25/2023, correction notices were sent to customers and distributors who were advised the following: 1) If you have an alternate method, please discard all unused material. 2) If you do not have an alternate method, please follow these steps, as applicable, to minimize patient risk. a) Flag all negative results reported to clinicians as possibly inaccurate until lots of unaffected product are used. b) Use results from an alternate clinical laboratory analyzer when troponin results are below or close to the cutoff and myocardial infarction is suspected. c) Perform serial sampling. Keep patients until at least 3 negative troponin values have been obtained. d) Use all Triage troponin results in conjunction with the patient s risk factors, clinical presentation, EKG, and other imaging. e) Consider recommendations by the ACC, ESC guidelines and the Fourth Universal Definition of Myocardial Infarction for monitoring a patient for a rise or fall pattern of troponin. 3) If you are experiencing issues with Proficiency testing, contact your local Technical Solutions Center. 4) Complete and return the confirmation of receipt form. 5) forward this notification if the product was distributed outside of your facility. If you have further questions, please contact: - For North America, Canada, Asia-Pacific, and Latin America, please call 858.552.1100 - For Europe, Middle East, and Africa, please call +353 (91) 412 474 - For China, please call 0400 920 9366 or +86 021 3217 8300 - EU authorized representative: MDSS GmbH, Tel.: +49-511-62628630, vigilance@mdss.com On 7/12/23, Update/Reminder Notices were sent informing customers to: Discontinue use of all affected devices. Use an unaffected lot number, obtain unaffected product, use an alternate method or send patients to an alternate testing site utilizing an alternate method. If an alternate method is not available, see above.

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

Lot, serial or model codes

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).

510(k) numbers

["K030286"]

PMA numbers

not on file

Product code

MMI

Firm FEI

3013982035

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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