Metrex Research
Romulus, MI, US
METREX RESEARCH appears in FDA device records in Romulus, MI. FDA records list 6 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Metrex Research between 1994 and 1998. The busiest year on record is 1994, with 3. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 2 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K981023 | KLEENASEPTIC | LRJ | Substantially Equivalent | |
| K950553 | COLDCIDE-2 | LRJ | Substantially Equivalent | |
| K950516 | COLDCIDE-10 | LRJ | Substantially Equivalent | |
| K931592 | METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE | MED | Substantially Equivalent | |
| K931052 | METRICIDE 28 | MED | Substantially Equivalent | |
| K930284 | METRICIDE | MED | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1722021 | 1000117344 | METREX RESEARCH | 28210 WICK RD., Romulus, MI 48174 US | 2026 | |
| 3003848022 | 3003848022 | Metrex Research LLC | 6650 Ronald Reagan Ave, Madison, WI 53704 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- LYUAccessory, Surgical Apparel
- EHAAligner, Beam, X-Ray
- MMPCover, Barrier, Protective
- LRJDisinfectant, Medical Devices
- PUIDrape, Surgical, Exempt
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- JOJIndicator, Physical/Chemical Sterilization Process
- EBALight, Surgical Headlight
- FSPLoupe, Diagnostic/Surgical
- MEDSterilant, Medical Devices
- EIAUnit, Operative Dental
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1402-2017 | CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces. | Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process. | Class II | Terminated | |
| Z-0414-2013 | The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection. | The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the device. | Class II | Terminated | |
| Z-2267-2012 | CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3 Surface Disinfectant, part number: 13-7900. CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas. | Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and respiratory discomfort. | Class II | Terminated | |
| Z-0402-2013 | Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas. | The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur. | Class II | Terminated | |
| Z-0444-2013 | Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. | The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500). | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain