🔍 RecallPedia

NucliSENS Lysis Buffer Extended lot for RES 76675

Class I - Dangerous
🏥 Medical Devices Recalled: October 18, 2017 BioMerieux SA Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
BioMerieux SA
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

NucliSENS Lysis Buffer Extended lot for RES 76675

Product Codes/Lot Numbers:

REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675

Distribution:

Distributed in: MD, CO, OH

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0086-2018

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