Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS… recallZ-1974-2023 · Quidel Cardiovascular Inc · initiated May 25, 2023

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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, [email protected] 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.

Recall details

Recall number

Z-1974-2023

Status

Open, Classified

Initiated by the company

May 25, 2023

Posted by the FDA

Jul 7, 2023

Recalling firm

Quidel Cardiovascular Inc

Quantity

16,194

Product code

MMI

FDA submissions

K030286

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

Product description

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

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

• Triage 97021HS

  Quidel Cardiovascular Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  1 recall42 reports
• Triage 97000HS

  Quidel Cardiovascular Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  1 recall10 reports
• Triage 97022HS

  Quidel Cardiovascular Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  1 recall1 report
• Triage 97000HSEU

  Quidel Cardiovascular Inc. · RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP.
  1 recall0 reports