Beckman Coulter recalls Access hsTnI High Sensitivity Troponin I reagent packs with specific lot numbers due to potential sample carryover causing contamination in high concentration tests.
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.
Beckman Coulter is recalling certain Access hsTnI High Sensitivity Troponin I reagent packs. Using these packs with very high troponin I concentrations may cause contamination that affects test results. This could lead to inaccurate cardiac tests if not addressed.
High concentration cardiac troponin I samples (>270,000 pg/mL) can carry over into the reagent pack during testing. This contamination may cause false positive results in subsequent tests if the reagent pack is reused without proper cleaning.
Laboratory users who have the specific lot numbers listed in the recall. Those testing cardiac troponin I at high concentrations are most at risk of inaccurate results.
Check the lot number on the reagent pack. The affected lots include 921491, 921638, 921631, 921750, 921805, 921831, 921943, 922000, 922039, 922040, 922062, 922145, 922146, 922338, 922440, 922545, 922547, 922713, 922714, 922722, 922897, 124235, 124339, 922898, 124340, 124348, 124353, 124688, 124354, 124355, 124356, 124357.
Look for the lot number on the reagent pack to determine if it is affected. Affected lots are listed in the recall.
Using high concentration cardiac troponin I samples (>270,000 pg/mL) with these reagent packs can cause carryover contamination, potentially leading to inaccurate test results.
Check the lot number on the reagent pack. Affected lots include 921491, 921638, 921631, 921750, and other specific numbers listed in the recall.
The recall does not specify a remedy, so no action is required beyond checking the lot number. However, if you used high concentration samples, you may need to clean the reagent pack or follow lab procedures.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0032-2022 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0032-2022 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
