Recall Z-0032-2022— Beckman Coulter Inc.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2021-08-09. It names 2 FDA 510(k) clearances: K172787, K172783. Product: Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK. 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..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-08-09
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.