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Manufacturer
Product
Class Reason
Beckman Coulter
Access Immunoassay Systems
Reagent Kit
II
Different results have been obtained using the same patient
samples on Access/Access 2 and UniCel Dxl platforms. Values
obtained with UniCel Dxl systems have been demonstrated to
have a positive bias compared to values obtained with Access
or Access 2 systems. (Z-1318-2010)
Beckman Coulter
UniCel DxH 800 Cellular Analysis
System
II
Problems related to host transmissions. This information only
affects instruments interfaced to a host system. (Z-1680-2010)
Beckman Coulter
LH 500 Series System; Unicel DxH
800 Cellular Analysis System
III
The system will substitute or omit the characters # @ [\] ‘ {I)
when the system is configured in a language other than English
or Chinese. The system will also omit the character ~ regardless of language, leaving a potential for specimen or patient
misidentification. (Z-1657/1658-2010)
Beckman Coulter
PrepPlus; PrepPlus 2
II
Dilution of reagent vials loaded onto the PrepPIus or PrepPlus
2 systems. This problem could result in dilution of affected antibody vials, which may diminish cellular fluorescence staining
and present a risk of erroneously low results. (Z-1758/1759-2010)
Beckman Coulter
Unicel DxH 800 Cellular Analysis
System
II
There is a potential for a false increase in platelet results due
to micro-bubbles. This situation could present a risk of falsely
increased platelet results in patient samples as diluent containers
are depleted. (Z-1905-2010)
Beckman Coulter
Access Immunoassay Systems AFP QC III
Vials of QC1 in the kits contain microbial contamination. Elevated CVs
may also be observed with the contaminated vials. (Z-2208-2010)
Beckman Coulter
Access Thyroglobulin Antibody II
Reagent
II
Reagent may produce inaccurate results due to a change in the
thyroglobulin that was used in the kits. (Z-2355-2010)
Beckman Coulter
LH500 Series System; Unicel
DxH800 Cellular Analysis System
III
Beckman Coulter identified four issues with systems. Issue 1: There is a
potential for misidentification to occur when the system is configured
in languages other than English or Chinese. The characters #, @, [,
\, ], ‘,{, |, } or ~ are substituted or omitted in other languages. Issue
2: Independent of language, the DxH800 omits the characters *?”
when used as part of the selected demographics including Specimen
ID and Patient ID. Issue 3: In the DxH 800, space(s) used as leading
character(s) in a Patient ID or Specimen ID can cause random insertion
of extra character(s) within that identifier. Issue 4: The LH500 instrument omits the tilde character (~) from the barcode when read by the
primary mode (automatic aspiration) scanner. This is independent of
language configuration on the system. (Z-2337/2338-2010)
Beckman Coulter
UniCel DxC and Synchron LX
Instruments
II
Instruments produced inaccurate (low) GLUCm results. False-low
results could affect or delay diagnosis or treatment. (Z-2388-2010)
Beckman Coulter
Access Immunoassay Systems Free II
T4 Reagent
Kit boxes may contain reagent packs labeled as “Access Vitamin
B12.” Using an Access Vitamin B12 reagent pack filled with Access Free T4 reagents may generate incorrect patient results.
(Z-2658-2010)
Beckman Coulter
Immage Immunochemistry Systems Buffer 1 (BUF1)
II
Some lots have been reported to cause high shifts in recovery
of control or patient samples. Quality control failures may result
after replacing BUF1 with a different lot. (Z-2195-2010)
Beckman Coulter
Synchron Gentamicin Reagent
II
The reagent produces false-low test results. A false-low result
can cause a patient to receive more medication than necessary.
(Z-2437-2010)
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