TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: (01)20812747018095 All lots are affected.
- 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:
- Haemonetics Corporation
- Reason for Recall:
- Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Product Codes/Lot Numbers:
UDI-DI: (01)20812747018095 All lots are affected.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1310-2022
Related Recalls
When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.
Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa.
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.