Berhring Nephelometer SystemN Latex CDT Kit (Carb Deficient Transferrin) (2020-03-05)

Starting date:

March 5, 2020

Posting date:

April 15, 2020

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-72715

Last updated: 2020-04-15

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  Reason
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  Affected products

Affected Products

Berhring Nephelometer SystemN Latex CDT Kit (Carb Deficient Transferrin)

Reason

Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N latex CDT kit lots (49729, 49849, 49985 and 50084) in comparison to the HPLC method. All affected kit lots contain reagents from the same bulk. The issue has been internally observed during performed shelf-life monitoring after 15 months. CDT results in absolute concentrations may be influenced by the patient's transferrin levels and, therefore, results are reported as a ratio of CDT to total transferrin, called

Affected products