Recall Z-1974-2023 ยท MMI Immunoassay Method, Troponin Subunit
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.
| Date | Jul 7, 2023 (initiated May 25, 2023) |
| Status | Open, Classified |
| 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 pat |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030286 | TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL Biosite Incorporated, Feb 21, 2003 |