Recall Z-2229-2019
Siemens Healthcare Diagnostics, Inc. · initiated July 15, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.
Codes / lots: Catalog Number RF440, SMN# 10444946 Lot # EA9227 UDI: 00842768013867EA922719081510444946840
Reason for recall
Negative Bias with Lot EA9227.
FDA-determined cause: Under Investigation by firm
Action taken
Siemens sent an Urgent Field Safety Notice letter dated July 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Review the letter with their Medical Director 2. Discontinue use and discard the kit. 3. Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. send a scanned copy of the completed form via email to or fax this completed form to the Customer Care Center at 312-275-7795. 4. If you have received any complaints of illness or adverse events associated with the product listed in the letter, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative. 5. Retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Details
- Recall number
- Z-2229-2019
- Initiated
- July 15, 2019
- Terminated
- August 12, 2021
- Product code
- JMG – Radioimmunoassay (Two-Site Solid Phase), Ferritin
- Quantity
- 815 kits
- Distribution
- Worldwide Distribution AK AR AZ CA CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS MT NC NE NH NJ NY OK OR PR SD TN TX VA VT WA WI
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE