Recall Z-2341-2019
Siemens Healthcare Diagnostics, Inc. · initiated June 27, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
Codes / lots: Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334
Reason for recall
Iincreased (falsely elevated) Albumin results compared to expected results
FDA-determined cause: Process change control
Action taken
Siemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter PP-19-002.A.US to the US customers June 27, 2019 and May 2019 via FedEx overnight delivery and email to regional countries for implementation Outside the US (OUS). Customers were instructed to contact their Siemens Healthineers Customer Care Center for further follow-up in case they experienced sporadically increased Albumin results compared to expected results. Customers were also instructed to complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days.
Details
- Recall number
- Z-2341-2019
- Initiated
- June 27, 2019
- Terminated
- May 27, 2020
- Product code
- JZW – Nephelometer
- Quantity
- 664 units
- Distribution
- Nationwide
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY