VITROS Chemistry Products Calcium (Ca) Slides (2016-05-19)

Starting date:

May 19, 2016

Posting date:

June 16, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals, Healthcare Professionals

Identification number:

RA-58896

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  Reason
• 
  Affected products

Affected products

1. VITROS Chemistry Products Calcium (Ca) Slides

Reason

Ortho Clinical Diagnostics (Ortho) has initiated this recall due to a potential for negatively biased serum sample results to be generated when using VITROS Ca Slides, Gen 29.

Ortho confirmed an average negative bias of -0.45 mg/dl (-0.11 mmol/l) within the serum reference interval (8.4 - 10.2 mg/dl or (2.10 - 2.55 mmol/l) when using VITROS Ca Slides, Gen 29.

Plasma and serum samples are similarly affected as both sample types use the same calibration parameters (math) when results are produced. Though unconfirmed, to date, Ortho has no indication that urine sample results, generated when using VITROS Ca Slides, Gen 29, are affected. As a result, customers are being instructed to discontinue the use of VITROS Ca Slides, Gen 29.

Affected products