🔍 RecallPedia

Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

Class I - Dangerous
🏥 Medical Devices Recalled: October 14, 2016 Helena Laboratories Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136 EXP 3-17 Model/Catalog Number: 5136 UDI: Primary DI - M52551360
  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:
Helena Laboratories, Inc.
Reason for Recall:
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

Product Codes/Lot Numbers:

Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136 EXP 3-17 Model/Catalog Number: 5136 UDI: Primary DI - M52551360

Distribution:

Distributed in: FL, IL, MN, MT, NY, OH, TN, TX, VA, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2434-2019

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