BioMerieux recalls specific lot of NucliSENS Lysis Buffer Extended for RES 76675 due to potential test inhibition from heme residue, risking inaccurate PCR results.
Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.
BioMerieux is recalling a specific lot of NucliSENS Lysis Buffer Extended for RES 76675 because heme residue from blood samples can cause PCR tests to fail. This affects users who rely on this buffer for diagnostic testing.
Heme residue from blood samples can interfere with PCR reactions, leading to uninterpretable test results. If an Internal Control is used, it may also be inhibited, causing the test to be invalid.
Users of this buffer for diagnostic testing, particularly those using it with whole blood or dried blood spot samples. Those performing PCR tests on the buffer are most at risk of inaccurate results.
Check for the lot number 17022802 on the packaging. This extended lot was sold with expiration date 01/28/2019 for RES 76675.
Look for lot number 17022802 on the packaging to confirm if the product is recalled.
The buffer may contain heme residue from blood samples that can inhibit PCR reactions, leading to inaccurate test results.
Using the recalled buffer could result in uninterpretable test results or invalid Internal Controls in PCR tests.
Check for lot number 17022802 with expiration date 01/28/2019 for RES 76675.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0086-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-0086-2018 from BioMerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
