NucliSENS Lysis Buffer (2020-01-14)

Starting date:

January 14, 2020

Posting date:

February 7, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72261

Last updated: 2020-02-07

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  Reason
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  Affected products

Affected Products

NucliSENS Lysis Buffer

Reason

Following a customer complaint about colored eluates, Biomérieux investigation has confirmed an issue with this specific lot 19040201 of NucliSENS Lysis Buffer ref. 200292, Occurring on whole blood samples or other specimen containing blood.  The presence of hemoglobin could cause the inhibition of the PCR resulting, in most of the cases in uninterpretable test results as also the extraction internal control (IC) would be inhibited, invalidating the test. In this case, there is a potential risk related to possible delayed results.

Considering that the NucliSENS Lysis Buffer is used in various protocols and downstream applications and assuming a conservative approach and the worst case scenario in which the IC would not be inhibited, or not used although it is part of good laboratory practices, the tests run with colored eluates could potentially result in false negative results.

To be noted that colored eluates only occurs on whole blood samples or other specimen containing blood, such as dry blood spots and stools (not on all claimed matrix), because of remaining hemoglobin in the eluate. Samples with no hemoglobin are not impacted with this issue and could be used with the lysis buffer lot 19040201 with expected performance.

Affected products