FDA Device recall Z-1616-2015
COULTER DxH Diluent, Catalog No. 628017, Part No. A59956
- FDA Device
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of COULTER DxH Diluent, Catalog No. 628017, Part No. A59956 by Beckman Coulter, citing 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 Dilu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1616-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-13 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | PR |
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.
Identifiers
| code_info | Lot No. 3099980 - 3512190, expiration dates: 17 April 2015 - 26 August 2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1616-2015%22
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