Data / Medical devices / United States / Radiometer America, Inc.
Radiometer America, Inc.: FDA-registered device maker in Middleburg Heights, OH, United States, 1 510(k) clearance
Radiometer America, Inc. is registered with the FDA (registration 1523456) in Middleburg Heights, OH, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 28, 2016. 44 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1523456
- Address
- 6836 Engle Rd, Middleburg Heights, OH, United States, 44130
- Owner or operator
- RADIOMETER MEDICAL APS (8020503)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- April 28, 1986
- Registered through
- 2026
- Brand names listed
- SAFEPICO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arterial Blood Sampling Kit | CBT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 28, 2016 | K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | JJY | Substantially Equivalent | Radiometer America, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 8, 2014 | 70103 | Class II | Terminated | ABL90 FLEX analyzer; Model number. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. | The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result. | accessdata.fda.gov |
| October 29, 2014 | 69813 | Class II | Terminated | Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, c | Negative drift on QC during in-use lifetime of CREA membranes can be observed. | accessdata.fda.gov |
| October 20, 2014 | 69663 | Class II | Terminated | HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 | Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. HemoCue Glucose 201 | accessdata.fda.gov |
| July 28, 2014 | 68982 | Class II | Terminated | RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control cl | accessdata.fda.gov | |
| October 15, 2013 | 66875 | Class II | Terminated | ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. | RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results. | accessdata.fda.gov |
| July 5, 2013 | 67066 | Class II | Terminated | pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using mult | RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results. | accessdata.fda.gov |
| June 10, 2013 | 67044 | Class II | Terminated | pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen). | RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibrat | accessdata.fda.gov |
| November 27, 2012 | 65843 | Class II | Terminated | TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pres | RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B. | accessdata.fda.gov |
| October 8, 2012 | 66108 | Class II | Terminated | Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood. | RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane. | accessdata.fda.gov |
| July 5, 2012 | 62503 | Class II | Terminated | The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, an | A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixe | accessdata.fda.gov |
| December 16, 2011 | 60929 | Not yet classified | Terminated | S1827 Crea Calibration solution 1,, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea Calibration Solution ) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish c | When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and | accessdata.fda.gov |
| September 27, 2011 | 60153 | Not yet classified | Terminated | TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM serie | Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use. | accessdata.fda.gov |
| April 7, 2011 | 58657 | Not yet classified | Terminated | Ca++ Membrane Units, Model #, and Model # used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. Calcium membrane j | Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause a positive bias resulting in calcium measuring errors. This situation poses a risk to the safety of patients, particularly | accessdata.fda.gov |
| January 12, 2011 | 58273 | Not yet classified | Terminated | ABL90 FLEX Portable Blood Gas Analyzer System, Part Number:, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automat | Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. If the device operator/user ignores the error message and continues to o | accessdata.fda.gov |
| November 1, 2010 | 57275 | Not yet classified | Terminated | ABL90 FLEX Blood Analyzer Part Number:. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in v | Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample "fails" the next result will inherit the patient data from the previous result. | accessdata.fda.gov |
| April 16, 2009 | 51986 | Not yet classified | Terminated | Waste bottles Part Numbers/Article Numbers: /D512 and /D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing. | When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle. | accessdata.fda.gov |
| March 26, 2009 | 51983 | Not yet classified | Terminated | Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box. | Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings. | accessdata.fda.gov |
| September 5, 2008 | 49468 | Not yet classified | Terminated | ABL7XX Calibration 1 Solution S1720. P/N S1720, Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-ox | The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these parameters and thereby the measured results for patient samples and quality controls will be biased. | accessdata.fda.gov |
| January 18, 2008 | 46686 | Not yet classified | Terminated | ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device). | Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results. | accessdata.fda.gov |
| June 22, 2007 | 38511 | Not yet classified | Terminated | Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers. | Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use. | accessdata.fda.gov |
| January 16, 2007 | 37167 | Not yet classified | Terminated | ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 | In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode. | accessdata.fda.gov |
| November 13, 2006 | 36812 | Not yet classified | Terminated | ABL 700 Series blood gas analyzers equipped with Software Version 3.833. | Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. This condition can influence analyzer results. When the protein removal program is run too frequently, more than once | accessdata.fda.gov |
| July 18, 2006 | 36009 | Not yet classified | Terminated | SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and each box contains 100 pou | Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps. | accessdata.fda.gov |
| July 6, 2006 | 36539 | Not yet classified | Terminated | Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer | Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is then edited and sent.....In both cases RADIANCE will transmit the original FI02 value, not the value that was edited. | accessdata.fda.gov |
| June 29, 2006 | 36007 | Not yet classified | Terminated | SafeClinitubes, Capillary caps (purple),. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: (D941P-240-85x1), Lot Code: R0048; Clinitubes Kits: (D957P-70-100x1), Lot Codes: | Leaking Capillary Caps- The dimensions and shapes of the capillary caps do not fit the capillary tubes correctly. This can cause the capillary tubes to leak. | accessdata.fda.gov |
| June 22, 2006 | 37526 | Not yet classified | Terminated | SafeClinitubes, REF, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas analysis. | The clinitubes are not able to be filled due to contamination with silicone during production. | accessdata.fda.gov |
| June 6, 2006 | 37530 | Class III | Terminated | Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF. The solution is used for quality check of blood gas analyzers. | The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45. | accessdata.fda.gov |
| May 22, 2006 | 35695 | Not yet classified | Terminated | Model # (pump tube for waste) & Model # (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx, component of the ABL700/800 Blood Gas Analyzers, also included in service kits part no. | An increased failure rate was observed with the yellow rubber tubing. The tubing was found to be leaking blood and solutions after distribution. | accessdata.fda.gov |
| May 1, 2006 | 35698 | Not yet classified | Terminated | Dri-Tek BG-OX Cartridge, Model #D7120, Cat. # Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device. | Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark. | accessdata.fda.gov |
| April 7, 2006 | 35696 | Not yet classified | Terminated | TCM4 Series Monitoring System (Base Unit) (affected device) CompactFlash cards: (Defective Device Component) | System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further. | accessdata.fda.gov |
| March 22, 2006 | 35775 | Not yet classified | Terminated | Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillar | Capilliary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport. | accessdata.fda.gov |
| November 1, 2005 | 35789 | Not yet classified | Terminated | D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor) | Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations | accessdata.fda.gov |
| October 31, 2005 | 35796 | Not yet classified | Terminated | ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21. | ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched. | accessdata.fda.gov |
| October 31, 2005 | 35663 | Not yet classified | Terminated | S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF, used with ABL700 Series Blood Gas Analyzers. | Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is actually the bar code for the rinse solution. | accessdata.fda.gov |
| September 29, 2005 | 34963 | Not yet classified | Terminated | Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004. | Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na). | accessdata.fda.gov |
| September 19, 2005 | 35788 | Not yet classified | Terminated | Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number:, distributed one (1) electrode per box. | Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument. | accessdata.fda.gov |
| June 17, 2005 | 35665 | Not yet classified | Terminated | D711, Reference Membranes, Part #, used with the ABL835 Blood Gas Analyzers. | The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range. | accessdata.fda.gov |
| June 17, 2005 | 34953 | Not yet classified | Terminated | Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series. | Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase. | accessdata.fda.gov |
| June 9, 2005 | 35774 | Not yet classified | Terminated | ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number:. | The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the pO2 sample results. | accessdata.fda.gov |
| May 24, 2005 | 35773 | Not yet classified | Terminated | Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are package | The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the package insert was too low to generate accurate Hct test results (The control ranges were acceptable for the glucose and lactate testing). | accessdata.fda.gov |
| March 2, 2005 | 35699 | Not yet classified | Terminated | Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic. | Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System. | accessdata.fda.gov |
| February 2, 2005 | 35700 | Not yet classified | Terminated | TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor) | Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped. | accessdata.fda.gov |
| February 1, 2005 | 35649 | Not yet classified | Terminated | D 744 Chloride membrane, CI, REF Model #, accessory to the ABL700 blood analyzer. | The CI membrane units generate too low values for status and sensitivity during calibration. | accessdata.fda.gov |
| January 12, 2005 | 35664 | Not yet classified | Terminated | D7120, BG-OX Cartridge, D7120 REF, and, cuvettes for the NPT7 series of blood gas analyzers. | QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH. | accessdata.fda.gov |
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Updated January 28, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.