Siemens Healthcare Diagnostics, Inc. Recall 88784
Description: Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Siemens Healthcare Diagnostics, Inc. Recall 88784 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0181-2022 |
| Event ID | 88784 |
| Event Description | Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| Quantity | 246 (US); 689 (OUS) |
| Recall Reason | The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention. |
| Device Classification | 20211103 |
| Device Code Info | All lots impacted |
| Center Classification Date | 20211028 |
| Recall Initiation Date | 20210920 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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