Medical device manufacturer, bioMérieux, has issued a medical device safety alert concerning its NucliSENS Lysis Buffer [Reference Number: 200292; Lot Number: 19040201; Expiry: 28 February 2021].
Following a customer complaint about colored eluates, the manufacturer investigation has confirmed an issue with this specific lot of the affected product occurring on whole blood samples or other specimen containing blood. Previous investigations for colored eluates highlighted that the issue could be multifactorial (quality of the blood, detergent concentration in Lysis), including pH of lysis buffer out of specification. Re-measurement of pH of the affected lot during current investigation showed an out of specification pH (7, 05).
According to the manufacturer, the root cause is a pH meter dysfunction leading to an erroneous pH measure during manufacturing step. As a consequence, the quantity of HCI added in the bulk was too high to adjust pH of the lysis buffer.
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.
The 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 the issue and could be used with the affected lot with expected performance.
Customers are required to take the following actions:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 15 January 2020