epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Summary
The FDA issued a Class II for epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 by Siemens Healthcare Diagnostics Inc. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0286-2025
Action Date
2024-11-13
Status
Ongoing
Category
device
Product Description
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Lot/Code Info: UDI-DI: 00809708121860; Lot Numbers: 08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60
Quantity Affected: 1292 units
Reason for Recall
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.
Distribution
US Nationwide. Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-24
Company
Norwood, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics Inc has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics Inc have FDA actions?
Siemens Healthcare Diagnostics Inc has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0286-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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