BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Manufactured: BC Thrombin Reagent Kit Lot 46751: 3673 kits BC Thrombin Reagent Kit Lot 47184: 3958 kits Total kits Distributed to Customers Domestic and Foreign: BC Thrombin Reagent Kit Lot 46751: 3549 kits BC Thrombin Reagent Kit Lot 47184: 2580 kits Product Code/ Lot# Date Manufactured Date Expired 46751 2016-11-01 2018-09-08 47184 2017-03-20 2019-02-21
- 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
- Reason for Recall:
- The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.
Product Codes/Lot Numbers:
Manufactured: BC Thrombin Reagent Kit Lot 46751: 3673 kits BC Thrombin Reagent Kit Lot 47184: 3958 kits Total kits Distributed to Customers Domestic and Foreign: BC Thrombin Reagent Kit Lot 46751: 3549 kits BC Thrombin Reagent Kit Lot 47184: 2580 kits Product Code/ Lot# Date Manufactured Date Expired 46751 2016-11-01 2018-09-08 47184 2017-03-20 2019-02-21
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0827-2018
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.