Recall Z-1014-2017— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2016-12-19, terminated 2017-05-12. It names 3 FDA 510(k) clearances: K140911, K120771, K081930. Product: DxH 600 Coulter Cellular Analysis System, Catalog No. B23858. Reason: Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-19
- Terminated
- 2017-05-12
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K140911 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
- K120771 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
- K081930 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
K-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
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
Reason for recall
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations.
Data sourced from openFDA. This site is unofficial and independent of the FDA.