Beckman Coulter Recalls

Hazard: The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This introduces a risk of the positive bias not being detected by QC with the potential that clinical correlation with other thyroid function tests will be inconsistent requiring additional testing; however the clinical assessment and treatment decisions are not made in isolation on a single test result especially, in the setting of thyroid function testing. False positive test results could lead to a euthyroid patient being interpreted clinically as having elevated thyroid function (hyperthyroid) or a hypothyroid patient being within the normal range. Such misdiagnoses may lead to inappropriate treatment of a euthyroid patient with anti-thyroid medications or hypothyroid patient not getting sufficient treatment since their free T3 test result demonstrates them to be in the euthyroid range.

Hazard: 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.

Hazard: Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

Hazard: Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.

Hazard: WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

Hazard: WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

Hazard: WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

Hazard: WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

Hazard: WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

Hazard: WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

Hazard: IRISpec CA failures for glucose.

Hazard: Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.

Hazard: Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.

Hazard: Missing splash guard which may expose users to hazardous materials. .

Hazard: Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.

Hazard: There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped when they reach the end of the outer lane which could result in Delay in providing patient with appropriate medical treatment. New sample needs to be drawn. Substantial discharge of biohazards material - Infection with a human transmissible blood-borne or animal pathogen which could result in Infection with a human transmissible blood-borne pathogen (e.g. infectious HBV, HCV, HIV).

Hazard: Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute

Hazard: There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.

Hazard: SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

Hazard: SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

Hazard: SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

Hazard: SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

Hazard: Software anomalies that may lead to the generation of erroneous results.

Hazard: SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

Hazard: SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

Hazard: specimens collected in transport media may result is false negative results when stored in certain conditions.

Hazard: Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

Hazard: Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

Hazard: Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

Hazard: Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.