BUN Reagent (BUN 2 x 300)

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

• • Ongoing Z-1257-2023 FDA Class II ·initiated 26 Jan 2023 ·on shared 510(k) K060256

  An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a remote probability of delayed results or reporting erroneous patient results. The subject nut bands were found to not meet the firm's specifications for hardness and had the incorrect material grain direction. Affected instruments were manufactured from December 28, 2017 to October 19, 2022 or had their nut bands replaced during the same period.

• • Terminated Z-0310-2018 FDA Class III ·initiated 6 Nov 2017 ·on shared 510(k) K060256

  Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

• • Terminated Z-0176-2015 FDA Class II ·initiated 6 Oct 2014 ·on shared 510(k) K060256

  Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system.

• • Terminated Z-2272-2016 FDA Class II ·initiated 22 Apr 2014 ·on shared 510(k) K060256

  Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.

• • Terminated Z-1035-2013 FDA Class II ·initiated 12 Feb 2013 ·on shared 510(k) K060256

  Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.

• • Terminated Z-0612-2013 FDA Class II ·initiated 1 Nov 2012 ·on shared 510(k) K060256

  It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.

• • Terminated Z-0123-2013 FDA Class II ·initiated 3 Sep 2012 ·on shared 510(k) K060256

  Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this alignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the Shuttle to Bar

• • Terminated Z-0059-2013 FDA Class II ·initiated 6 Jul 2012 ·on shared 510(k) K060256

  The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Aliquotter (UCTA) serial numbers between 547 and 574 may cause a hardware motion error (ID0x08000501).

• • Terminated Z-1972-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010 ·on shared 510(k) K060256

  The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator could be cut by the hose clamps, which could in turn result in increased exposure to any waste products (biohazards) that might be present on the assembly.

• • Terminated Z-1936-2011 FDA Unclassified (pre-2012) ·initiated 5 Oct 2010 ·on shared 510(k) K060256

  The recall was initiated because Beckman Coulter confirmed Access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. Over time, waste bottles can degrade, become brittle and potentially crack.

• • Terminated Z-0607-2011 FDA Unclassified (pre-2012) ·initiated 13 Aug 2010 ·on shared 510(k) K060256

  This recall was initiated because Beckman Coulter has received reports of erroneous test results being reported as a result of assay reagent packs being transferred between systems. Erroneous results will be generated as a result of missing or incorrect assay reagents. In these cases both false positive and false negative results are possible, depending upon the assay configuration.

• • Terminated Z-1619-2011 FDA Unclassified (pre-2012) ·initiated 10 Aug 2010 ·on shared 510(k) K060256

  The recall was initiated because Cartridge Glucose (GLU) on UniCel DxC and Synchron LX instruments may give falsely high results for moderately hemolysed samples. The Impact: (1) Neonatal samples drawn by lancets are more likely to be hemolysed to a degree sufficient to cause interference with glucose estimation and are a special at-risk population, (2) Other hemolysed samples may be similar

• • Terminated Z-2388-2010 FDA Unclassified (pre-2012) ·initiated 15 Apr 2010 ·on shared 510(k) K060256

  UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.

• • Terminated Z-2590-2010 FDA Unclassified (pre-2012) ·initiated 25 Feb 2010 ·on shared 510(k) K060256

  Beckman Coulter is initiating a recall on their UniCel DxC Clinical Systems (880i, 860i,680i and 660i Systems with serial number <2760 that have software version 4.9.01 installed and have the VME Motorola ICS board) because they may exhibit issues with stat sample rack loading, causing a possible delay in results.

• • Terminated Z-2442-2010 FDA Unclassified (pre-2012) ·initiated 18 Jan 2010 ·on shared 510(k) K060256

  The recall was initiated due to " A loose Aliquot Probe tube fitting in the Closed Tube Aliquotter (CTA), may result in erroneous Access immunoassay results or Synchron chemistry results". This may result in dilution of the sample with Wash Buffer; patient results can potentially be affected for Access immunoassays or Synchron chemistries. Access Quality Control may also be affected if run throug

• • Terminated Z-0863-2010 FDA Unclassified (pre-2012) ·initiated 4 Jan 2010 ·on shared 510(k) K060256

  Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results.

• • Terminated Z-0856-2010 FDA Unclassified (pre-2012) ·initiated 28 Oct 2009 ·on shared 510(k) K060256

  This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and stopping sample processing, the system will post a yellow caution event and continue to operate with the dispense plate in an elevated position until the instrument

• • Terminated Z-2633-2011 FDA Unclassified (pre-2012) ·initiated 23 Jul 2009 ·on shared 510(k) K060256

  The recall was initiated because the Wash Concentrate Tube Assembly 142 may fail to deliver the appropriate amount of wash concentrate on some SYNCHRON DxC Systems due to an accumulation of crystals. The impact of this issue would include: (1) Quality Control and patient results can potentially be affected. (2) If system has been calibrating properly and Quality Control is recovering within es

• • Terminated Z-2771-2011 FDA Unclassified (pre-2012) ·initiated 7 May 2009 ·on shared 510(k) K060256

  The recall was initiated after Beckman Coulter confirmed reports of inaccurate Access Intrinsic Factor Ab test results displayed on, or printed from, the UniCel Dxl portion of an integrated workstation listed above. The problem is limited to numerical Intrinsic Factor Ab results produced on integrated systems running UniCel Dxl system software version 4.0, 4.1, or 4.2. The DxC portion of your inte

• • Terminated Z-0914-2010 FDA Unclassified (pre-2012) ·initiated 9 Oct 2008 ·on shared 510(k) K060256

  The recall was initiated after Beckman Coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect precision. The failure is limited to those UniCel DXI 800, DXI 600, and DxC 880i systems which have a pump identified with one of the new pump manufacturing numbers (Mfg. Nos.) listed ab

• • Terminated Z-1375-2012 FDA Unclassified (pre-2012) ·initiated 11 Sep 2008 ·on shared 510(k) K060256

  The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.

• • Terminated Z-2386-2008 FDA Unclassified (pre-2012) ·initiated 3 Apr 2008 ·on shared 510(k) K060256

  The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision.

• • Terminated Z-1183-2008 FDA Unclassified (pre-2012) ·initiated 17 Oct 2007 ·on shared 510(k) K060256

  Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering.

• • Terminated Z-1098-2008 FDA Unclassified (pre-2012) ·initiated 5 Apr 2007 ·on shared 510(k) K060256

  Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags or motion errors. -If a stall occurs during a GLUm test near the time of sample inject, results may be affected. -Affected GLUm results may be high or low.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

BUN Reagent (BUN 2 x 300) EUDAMED

Synchron GUDID

Generic Name

Urea IVD, kit, enzyme spectrophotometry

Model / Ref / Catalog

442750

Primary DI / UDI-DI

D-442750PP EUDAMED

15099590233082 GUDID

Basic UDI-DI

B-442750PP

510(k) Number

K060256 ↗

FDA Product Code

CDQ

EMDN Code

W01010204 Urea/blood urea nitrogen

GMDN Term

Urea IVD, kit, enzyme spectrophotometry

Device Class

Class IVD General EUDAMED

Class II GUDID

Regulation Number

862.1770

EU market of registration

Ireland

GUDID distribution status

In Commercial Distribution

EUDAMED SRN

US-MF-000010288

Authorised representative

Beckman Coulter Ireland Inc. IE-AR-000000886

• Access Testosterone

  Class B

  CE/IVDR

• Access IL-6

  Class C

  CE/IVDR

• Access Ultrasensitive hGH

  Class B

  CE/IVDR

• Access Thyroglobulin

  Class C

  CE/IVDR

• Access HBs Ag

  IVD Annex II List A

  CE/IVDD

• Access Ultrasensitive Insulin

  Class C

  CE/IVDR

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