ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88767009 4/28/2013 88787009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90253010 6/2/2013 91934010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92396011 8/12/2013 93363011 8/12/2013 95088011 8/12/2013
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Siemens Healthcare Diagnostics, Inc
- Reason for Recall:
- Negative bias in patient samples for Vitamin D
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
Product Codes/Lot Numbers:
Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88767009 4/28/2013 88787009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90253010 6/2/2013 91934010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92396011 8/12/2013 93363011 8/12/2013 95088011 8/12/2013
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1120-2013
Related Recalls
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Siemens Healthcare Diagnostics
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Siemens Healthcare Diagnostics
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.