epoc BGEM BUN Test Card for epoc Blood Analysis System
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards due to risk of inaccurate pH and carbon dioxide readings that could lead to inappropriate or missed treatment of acid-base disorders.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a high-risk hazard (inaccurate blood gas and electrolyte measurements that could lead to serious misdiagnosis or inappropriate treatment) with potential for harm, but no reported illnesses or injuries are stated in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling the epoc BGEM BUN Test Card (25 pack) for the epoc Blood Analysis System. The affected product can produce discrepant low pH and measured total carbon dioxide (mTCO2) results, along with corresponding incorrect calculated values, in arterial, venous, and capillary patient samples.
Erroneously low pH or mTCO2 readings can lead to inappropriate treatment of nonexistent acidosis (respiratory or metabolic) or failure to diagnose alkalosis (true high pH: respiratory or metabolic). This can result in unnecessary medical interventions or failure to deliver appropriate treatment.
The product was distributed nationwide in the US and in Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, the Philippines, and Mexico. Affected lot numbers are 01-26024-70, 01-26026-70, 01-26028-70, 01-26030-70, 02-26027-80, and 02-26028-80, with Siemens Material Number 10736515 and UDI-DI 00809708121860.
If you have affected test cards, contact Siemens Healthcare Diagnostics Inc for guidance on return or replacement.
The recalled product
- Product
- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
- Manufacturer
- Siemens Healthcare Diagnostics Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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)
Distribution
Distributed nationwide across the United States.
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