—#210439

Product

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

FDA product code: CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K200107
Affected lot / code info: UDI-DI: 00809708121860; Lot Numbers: 08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An Urgent Medical Device Correction letter dated September 2024 was sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " If you are a distributor, please ensure your customers receive this UMDC letter. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " Adverse reactions or quality problems experienced with the use of the affected products listed in the above table may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " For any questions, you may call Siemens Healthineers Technical Solutions Center at 877-229-3711.

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc
Address: 2 Edgewater Dr, Norwood, Massachusetts 02062-4637

Distribution

Distribution pattern: US Nationwide. Canada.

Timeline

Recall initiated: 2024-09-24
Posted by FDA: 2024-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210439. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.