Recall Z-0032-2022 ยท MMI Immunoassay Method, Troponin Subunit
Beckman Coulter Inc.
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
| Date | Aug 9, 2021 |
| Status | Open, Classified |
| Reason | Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples. |
| Root cause | Unknown/Undetermined by firm |
| Action | During the week of 08/09/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via mail or email informing customer of possible carryover with in-use, open (punctured) hsTnI reagent packs, and the impact of carryover on patient samples that are tested from the same reagent pack as a sample with a high cardiac troponin (cTnI) concentration >270,000 pg/mL (ng/L), or the carryover may also impact a different reagent pack. Clinical carryover can affect the results of all subsequent samples that are tested from the affected pack. Customer are instructed to: - If an hsTnI resul |
| Quantity | 293,640 kits |
| Distribution | U.S.: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, NC, ND, NE, NV, NJ, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY O.U.S.: Algeria, Andorra, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzeg |
| FDA record | Open on fda.gov |