EVERYDAY CHALLENGES MEET EVERYDAY SOLUTIONS
- Architect Ci4100 Test Menu
- Architect Ci4100 Manuale
- Abbott Ci4100 System Specifications
By integrating immunoassay and chemistry testing on a single platform along with advanced technologies like CHEMIFLEX and FlexRate, the ARCHITECT ci4100 can offer your laboratory the same robust science that larger-volume labs employ.
DFDM Policy & Procedure Manual for A/Es and Consultants T-4 5.B Construction Specifications - Project Manual 1. Division One - Bidding Requirements 3. Invitation to Bid 4. Instructions to Bidders 5. Read-Only Division 01 Forms 7. Conditions of the Contract – General Requirements 8. Supplementary General Conditions 9. If damage is discovered, follow the procedure in ARCHITECT System Operations Manual Section 9 Service and maintenance, Component replacement, Replace a cuvette (c4000, c8000, and c16000). Once inspection has been completed, re‐install the cuvette segments into the ARCHITECT and verify proper installation.
Refer to the Operations manual for operational precautions, limitations and hazards. Refer to assay instructions for use for the latest product speci cations. manuals and instructions for use can be found on www.abbottdiagnostics.com
Seamless Integration
• Immunoassay and clinical chemistry testing on a single platform
• ≤0.1 ppm (insigni cant level) sample-to- sample carryover
Accurate Results Fast
• Throughput up to 800 chemistry tests and 100 immunoassay tests per hour†
• Immediate sTAT processing
• up to seven customizable priority bays
Easy to Operate
• Intuitive software with a single interface
• Access to reagents, samples and supplies
While system is in process
• Multiple tube types and sizes
• Expanded calibration and QC capabilities
ARCHITECt, CHEMIFLEX, i1000sr, ci4100, c4000, smartWash, FlexRate, Put science on your side. and Abbottlink are trademarks of Abbott laboratories in various jurisdictions.
All ARCHIteCt analyzers are Class 1 laser Products.
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Architect Ci4100 Manuale
510(k) | | | DeNovo | | | Registration & Listing | | | Adverse Events | | | Recalls | | | PMA | | | HDE | | | Classification | | | Standards |
CFR Title 21 | | | Radiation-Emitting Products | | | X-Ray Assembler | | | Medsun Reports | | | CLIA | | | TPLC |
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ABBOTT MANUFACTURING, INC. ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER | Back to Search Results |
| Catalog Number 2P24-40 | Device Problems Thermal Decomposition of Device (1071); Mechanical Problem (1384); Smoking (1585); Device Operates Differently Than Expected (2913) | Patient Problem No Known Impact Or Consequence To Patient (2692) | Event Date 01/20/2011 | Event Type Malfunction | Event Description | The customer is integrating a new architect ci4100 system in their lab. The customer states that the system was not running at the time that a loud pop was heard with visible smoke and a burning smell coming from the uninterrupted power supply (ups). The customer cut all power to the system and a service call was initiated. No injuries were reported or damage to the surrounding lab environment. The system is not generating any results for patient management at this time. | Manufacturer Narrative | (b)(4). An abbott field service engineer (fse) visited the customer site and noted that the issue at this customer site was caused by a non-abbott product. The damaged uninterrupted power supply (ups) was replaced under warranty. The damaged ups was returned to synergy (the manufacturer). A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The architect system operations manual ((b)(4), january, 2010) contains information to address the customer's current issue. There is no indication that the c4000 contributed to or caused the issue with the ups. Concomitant medical products: ups model: synergy 2 (b)(4). Evaluation, method: review of complaint tracking and trending; field service intervention. | Search Alerts/Recalls |
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New Search | Submit an Adverse Event Report |
Abbott Ci4100 System Specifications
Type of Device | AUTOMATED CHEMISTRY ANALYZER |
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Manufacturer (Section D) | ABBOTT MANUFACTURING, INC. | 1921 hurd drive | irving TX 75038 |
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Manufacturer (Section G) | ABBOTT MANUFACTURING, INC. | 1921 hurd drive | irving TX 75038 |
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Manufacturer Contact | noemi kondos rn, bsn | 200 abbott park road | dept. 09b9, ap50 | abbott park, IL 60064-3537 | 8479375120 |
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MDR Report Key | 1980024 |
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MDR Text Key | 1897979 |
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Report Number | 1628664-2011-00061 |
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Device Sequence Number | 1 |
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Product Code | JJE |
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Combination Product (Y/N) | N |
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Reporter Country Code | US |
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PMA/PMN Number | K980367 |
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Number of Events Reported | 1 |
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Summary Report (Y/N) | N |
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Report Source | Manufacturer |
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Source Type | Health Professional |
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Reporter Occupation | MEDICAL TECHNOLOGIST |
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Type of Report | Initial |
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Report Date | 01/20/2011 |
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1 Device Was Involved in the Event |
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1 Patient Was Involved in the Event |
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Date FDA Received | 02/07/2011 |
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Is This An Adverse Event Report? | No |
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Is This A Product Problem Report? | Yes |
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Device Operator | HEALTH PROFESSIONAL |
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Device Catalogue Number | 2P24-40 |
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Was Device Available For Evaluation? | Yes |
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Is The Reporter A Health Professional? | Yes |
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Date Manufacturer Received | 01/20/2011 |
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Was Device Evaluated By Manufacturer? | Device Not Returned To Manufacturer |
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Date Device Manufactured | 09/01/2010 |
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Is The Device Single Use? | No |
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Is this a Reprocessed and Reused Single-Use Device? | No |
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Type of Device Usage | Invalid Data |
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Patient TREATMENT DATA |
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Date Received: 02/07/2011 Patient Sequence Number: 1 |
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Treatment |
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ARC/AEROSET UPS LN: 2P46-20 |
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