FDA Device recall Z-2481-2015
COULTER ISOTON 4 Diluent, Catalog No. 8547148
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of COULTER ISOTON 4 Diluent, Catalog No. 8547148 by Beckman Coulter, citing beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2481-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-22 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
Reason
Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.
Identifiers
| code_info | Lot Numbers: 18203F-18206F. |
|---|
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-2481-2015%22
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