Overview of recall records associated with Beckman Coulter, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 165, Class III: 9, Class I: 5.
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)…
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and…
The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total…
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total…
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays (Free T3-REF A13422, Total…
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total…
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total…
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total…
Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associated with…
A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of…
A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of…
The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in…
Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false…
Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.
Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false…
A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that Data…
Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results,…
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in…
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in…
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in…
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in…
This page summarizes recall records in which the official source identifies Beckman Coulter, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
