Reference: 98416211. Lot: ZD5013

Reticulocyte staining in automated Sysmex Hematology analyzers.

CS-2100I, CS-2000I

The coagulation analyzers CS2000I / CS2100I are fully automated instruments for quantitative coagulation, immunological and chromogenic coagulation tests. Continuous random access. Uses deplasma samples for in-vitro diagnostic (IVD) assays of PT, APTT, TT, fibrinogen, D-Dimero; AT-III; PLG; PC and individual factors I to XIII. It is an automated system that reports the values of the tests and communicates the clinical results of the patient. The reagents that are used with the SYSEX®CS2000I / CS2100I devices have respective health records.

Reference. 6510299001; Lots: A5053 and A5054

DETERMINATION OF DIFFERENT ANALYTS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION

The coagulation analyzers CS2000I / CS2100I are fully automated instruments for quantitative decoagulation tests by coagulometry, immunological and chromogenic. Continuous random access. Uses plasma samples for in-vitro diagnostic tests (IVD) of PT, APTT, TT, fibrinogen, D-Dimero, AT-III; PLG; PC and individual factors I to XIII. It is in an automated system that reports the values of the tests and communicates the results of the patient's clinicians. The reagents that are used with the SYMEX CS2000I / CS2100I equipment have their respective health records.

CA-620 and CA-660

Indicated to perform quantitative coagulation tests by coagulometry and chromogenics. It uses plasma samples for in vitro diagnostic tests (IVD) of PT, APTT, TT, fibrinogen and individual factors.

No. of lots: P7001, P7002 and P7003.

DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANISM

Blood cell counter

Enzyme immunoassay system

Blood cell counter

Automatic blood image analyzer

Blood coagulation analyzer

Enzyme immunoassay system

Model: , Affected: all systems with software versions up to and including SW 00-60

Model: Models: CS-2100i & CS-2000i, Affected: All serial numbers

Model: Catalogue number 10488062, Affected:

Model: Catalogue number - 10488064, 10488062 and 10709128 respectively, Affected:

Model: , Affected: CS-2000i and CS-2100i

Model: , Affected: Sysmex XN-550

Model: , Affected: Sysmex CA-620 and Sysmex CA-660

Model: , Affected: XN-10: all instruments, XN-20: all instruments

Model: , Affected: XN-L series instruments: version 00-13 and above

Model: , Affected: Sysmex® CS-5100, affected serial ID 24425 and below

Model: , Affected: Affected Lots: A6027, A6028, A6029, A6030, A6031, A6032, A6033, A6034, A6035, A6037, A6039, A7001, A7002, A7004

Model: , Affected: Lots 6051 – 6090.

Model: SN: 16489, Affected: