medical MODERATE Updated 2017-11-15

BioMerieux SA recalls NucliSENS Lysis Buffer Extended lot for RES 76675

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Recalled Product

NucliSENS Lysis Buffer Extended lot for RES 76675

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Hazard / Issue

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.

Issued by

FDA

Affected States: MD, CO, OH
Lot/Code Info: REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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