epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Ma...
Reason for Recall / Hazard
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.
Product Description & Identification
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Affected Products
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Additional Source Details
| Field | Value |
|---|---|
| City | Norwood |
| State | MA |
| Event id | 98680 |
| Address 1 | 2 Edgewater Dr |
| Code info | Siemens Material Number (SMN): 10736515; UDI-DI: 00809708121860; Lot numbers: 01-26024-70, 01-26026-70, 01-26028-70, 01-26030-70 (OUS only), 02-26027-80, 02-26028-80 (OUS only); |
| Postal code | 02062-4637 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 71725 (38025 US, 33700 OUS) |
| Reason for recall | Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260402 |
| Initial firm notification | Letter |
| Center classification date | 20260429 |
Overview
- Recalling FirmSiemens Healthcare Diagnostics Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.