Sysmex Blood Coagulation Analyzer CS-2000i, CS-2100i and CS-5100 (2014-07-08)

Starting date:

July 8, 2014

Posting date:

August 8, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-40961

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  Reason
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  Affected products

Recalled products

1. Sysmex Blood Coagulation Analyzer CS-2000i
2. Sysmex Blood Coagulation Analyzer CS-2100i
3. Sysmex Blood Coagulation Analyzer CS-5100

Reason

Siemens Healthcare Diagnostics has confirmed a carry-over risk on Sysmex CS systems due to the following applications using CA-clean I (964-0631-3) for sample probe rinse:

• Protein C with protein C reagent (OQYG11)
• Protein S with protein S AC reagent (OPAP03)
• Factor V Leiden with proc global reagent (OQLS13)

Under certain circumstances the carry-over might impact results for Factor V with Innovin, Factor XII with Dade Actin FSL, Berichrom F XIII, Innovance D-dimer assays.

In case of Innovance D-Dimer, only frozen samples are concerned by a potential carry-over. No impact by carry-over was observed with Innovance D-Dimer when using fresh normal plasma or control plasma.

Affected products