ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ADVIA CH DBIL_2 (20 mL) 492068 (01)00630414513089(10)492068(17)20210728 ADVIA CH DBIL_2 (20 mL) 486501 (01)00630414513089(10)486501(17)20210628 ADVIA CH DBIL_2 (20 mL) 478164 (01)00630414513089(10)478164(17)20210328 ADVIA CH DBIL_2 (20 mL) 472667 (01)00630414513089(10)472667(17)20210228 ADVIA CH DBIL_2 (20 mL) 469068 (01)00630414513089(10)469068(17)20201228 ADVIA CH DBIL_2 (20 mL) 462448 (01)00630414513089(10)462448(17)20201028 ADVIA CH DBIL_2 (20 mL) 455476 (01)00630414513089(10)455476(17)20200728 ADVIA CH DBIL_2 (20 mL) 452841 (01)00630414513089(10)452841(17)20200628 ADVIA CH DBIL_2 (20 mL) 447337 (01)00630414513089(10)447337(17)20200528 ADVIA CH DBIL_2 (20 mL) 436518 (01)00630414513089(10)436518(17)20200228 ADVIA CH DBIL_2 (70 mL) 486509 (01)00630414513065(10)486509(17)20210628 ADVIA CH DBIL_2 (70 mL) 478169 (01)00630414513065(10)478169(17)20210328 ADVIA CH DBIL_2 (70 mL) 472672 (01)00630414513065(10)472672(17)20210228 ADVIA CH DBIL_2 (70 mL) 469073 (01)00630414513065(10)469073(17)20201228 ADVIA CH DBIL_2 (70 mL) 462453 (01)00630414513065(10)462453(17)20201028 ADVIA CH DBIL_2 (70 mL) 462459 (01)00630414513065(10)462459(17)20201028 ADVIA CH DBIL_2 (70 mL) 455481 (01)00630414513065(10)455481(17)20200728 ADVIA CH DBIL_2 (70 mL) 452846 (01)00630414513065(10)452846(17)20200628 ADVIA CH DBIL_2 (70 mL) 447351 (01)00630414513065(10)447351(17)20200528 ADVIA CH DBIL_2 (70 mL) 447357 (01)00630414513065(10)447357(17)20200528 ADVIA CH DBIL_2 (70 mL) 458975 (01)00630414513065(10)458975(17)20200528 ADVIA CH DBIL_2 (70 mL) 436523 (01)00630414513065(10)436523(17)20200228
- 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:
- Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin.
Product Codes/Lot Numbers:
ADVIA CH DBIL_2 (20 mL) 492068 (01)00630414513089(10)492068(17)20210728 ADVIA CH DBIL_2 (20 mL) 486501 (01)00630414513089(10)486501(17)20210628 ADVIA CH DBIL_2 (20 mL) 478164 (01)00630414513089(10)478164(17)20210328 ADVIA CH DBIL_2 (20 mL) 472667 (01)00630414513089(10)472667(17)20210228 ADVIA CH DBIL_2 (20 mL) 469068 (01)00630414513089(10)469068(17)20201228 ADVIA CH DBIL_2 (20 mL) 462448 (01)00630414513089(10)462448(17)20201028 ADVIA CH DBIL_2 (20 mL) 455476 (01)00630414513089(10)455476(17)20200728 ADVIA CH DBIL_2 (20 mL) 452841 (01)00630414513089(10)452841(17)20200628 ADVIA CH DBIL_2 (20 mL) 447337 (01)00630414513089(10)447337(17)20200528 ADVIA CH DBIL_2 (20 mL) 436518 (01)00630414513089(10)436518(17)20200228 ADVIA CH DBIL_2 (70 mL) 486509 (01)00630414513065(10)486509(17)20210628 ADVIA CH DBIL_2 (70 mL) 478169 (01)00630414513065(10)478169(17)20210328 ADVIA CH DBIL_2 (70 mL) 472672 (01)00630414513065(10)472672(17)20210228 ADVIA CH DBIL_2 (70 mL) 469073 (01)00630414513065(10)469073(17)20201228 ADVIA CH DBIL_2 (70 mL) 462453 (01)00630414513065(10)462453(17)20201028 ADVIA CH DBIL_2 (70 mL) 462459 (01)00630414513065(10)462459(17)20201028 ADVIA CH DBIL_2 (70 mL) 455481 (01)00630414513065(10)455481(17)20200728 ADVIA CH DBIL_2 (70 mL) 452846 (01)00630414513065(10)452846(17)20200628 ADVIA CH DBIL_2 (70 mL) 447351 (01)00630414513065(10)447351(17)20200528 ADVIA CH DBIL_2 (70 mL) 447357 (01)00630414513065(10)447357(17)20200528 ADVIA CH DBIL_2 (70 mL) 458975 (01)00630414513065(10)458975(17)20200528 ADVIA CH DBIL_2 (70 mL) 436523 (01)00630414513065(10)436523(17)20200228
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1538-2020
Related Recalls
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Siemens Healthcare Diagnostics
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;
Siemens Healthcare Diagnostics
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Siemens Healthcare Diagnostics
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.