NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 618201, 619200, 618263
  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:
Perkinelmer
Reason for Recall:
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.

Product Codes/Lot Numbers:

Lot Numbers: 618201, 619200, 618263

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0688-2013

Related Recalls

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The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.

Dec 8, 2015 Other Medical Devices Nationwide View Details β†’