FDA Medical devices recall ·
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System… recall
- Recall number
- Z-0286-2025
- Date
- (initiated September 24, 2024)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
2 Edgewater Dr, Norwood, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1292 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Why was it recalled?
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00809708121860; Lot Numbers: 08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60
Distribution
US Nationwide. Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0286-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.