BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    BD FACSLyric Flow Cytometer serial numbers: Z662875000001, Z662875000007, Z662875000008, Z662875000009, Z662875000011, Z662875000012, Z662875000013, Z662875000014, Z662875000015, Z662875000016, Z662875000017, Z662875000018.
  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:
Becton, Dickinson and Company, BD Biosciences
Reason for Recall:
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes

Product Codes/Lot Numbers:

BD FACSLyric Flow Cytometer serial numbers: Z662875000001, Z662875000007, Z662875000008, Z662875000009, Z662875000011, Z662875000012, Z662875000013, Z662875000014, Z662875000015, Z662875000016, Z662875000017, Z662875000018.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0066-2020

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