Recall Z-2158-2017— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-04-24, terminated 2018-05-22. It names 3 FDA 510(k) clearances: K140911, K120771, K081930. Product: UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.. Reason: There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-24
- Terminated
- 2018-05-22
- 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
UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
Reason for recall
There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
Data sourced from openFDA. This site is unofficial and independent of the FDA.