International Remote Imaging Systems
North Attleboro, MA, US
International Remote Imaging Systems appears in FDA device records in North Attleboro, MA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to International Remote Imaging Systems carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Iris Diagnostics510(k), enforcement report, recall
510(k) clearance history
FDA records hold 5 510(k) clearances for International Remote Imaging Systems between 1995 and 2010. The busiest year on record is 1995, with 1. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091539 | IQ 200 URINE ANALIZER BODY FLUIDS MODULE | GKL | Substantially Equivalent | |
| K072640 | IRISPEC,CA/CB/CC | JJW | Substantially Equivalent | |
| K030600 | AUTION JET AJ-4270 URINE ANALYZER | KQO | Substantially Equivalent | |
| K013783 | AUTION MAX AX-4280 URINALYSIS SYSTEM | KQO | Substantially Equivalent | |
| K945913 | IRISPEC URINE CHEMISTRY CONTROL PART A AND B | JJW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2441-2015 | iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. | Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling. | Class II | Terminated | |
| Z-0857-2015 | RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes. | Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time. | Class II | Terminated | |
| Z-1328-2013 | Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series. | The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples. | Class II | Terminated | |
| Z-2124-2012 | IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only. | The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive. | Class III | Terminated | |
| Z-0884-05 | IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074. | Nonconformance to performance specifications. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain