🔍 RecallPedia

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

Class I - Dangerous
🏥 Medical Devices Recalled: October 22, 2021 MEDLINE INDUSTRIES, LP - Northfield Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954
  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:
MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall:
Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

Product Codes/Lot Numbers:

Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1140-2022

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