Home › Siemens Healthcare Diagnostics Inc. › Atellica IM Multi-Diluent 11
Atellica IM Multi-Diluent 11
Siemens Healthcare Diagnostics Inc. · Model 10995641 · UDI-DI 00630414599595
10
510(k) clearances
144
Adverse events
13
Recalls
54
Facilities
Description
Multi-Diluent 11 Atellica IM - CONS (Bottle) 2 x 5mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-10 | Beckman Coulter, Inc. | Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. |
| 2023-05-31 | Beckman Coulter, Inc. | Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. |
| 2018-01-24 | Mindray DS USA, Inc. dba Mindray North America | Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevate |
| 2018-01-24 | Mindray DS USA, Inc. dba Mindray North America | Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated |
| 2015-07-22 | Beckman Coulter Inc. | 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. |
| 2015-07-22 | Beckman Coulter Inc. | 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. |
| 2015-04-13 | Beckman Coulter Inc. | 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 |
| 2014-08-25 | Beckman Coulter Inc. | Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in faile |
| 2006-12-22 | Abbott Laboratories | Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire |
| 2006-04-17 | Abbott Laboratories | High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.