FDA Class II Recall: epoc BGEM BUN Test Card (25 pk) for… by Siemens Healthcare Diagnostics Inc — Recall Details

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; -- and the recall number Z-2005-2026. If it matches, stop using or distributing it and contact Siemens Healthcare Diagnostics Inc or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Siemens Healthcare Diagnostics Inc and the affected product is described in FDA's record as: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2005-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Siemens Healthcare Diagnostics, Inc.’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Siemens Healthcare Diagnostics, Inc.: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;) and recall number Z-2005-2026, then follow Siemens Healthcare Diagnostics Inc's recall instructions.

Has Siemens Healthcare Diagnostics Inc had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Siemens Healthcare Diagnostics Inc, including 3 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2005-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions