Recall Z-1616-2015— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2015-04-13, terminated 2015-10-01. It names 2 FDA 510(k) clearances: K120771, K081930. Product: COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.. Reason: Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may eventually result in a compromised HGB chamber..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-13
- Terminated
- 2015-10-01
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
2 on FDA's record- 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
COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.
Reason for recall
Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may eventually result in a compromised HGB chamber.
Data sourced from openFDA. This site is unofficial and independent of the FDA.