IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) --- Test code: RCK Color: Orange. F
FDA device recall Z-1274-2012 · posted 2012-03-21 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics
- Reason for recall
- Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.
- Action taken
- Siemens sent an "URGENT DEVICE RECALL" letter dated January 2012 to all affected customers. The letter identifies the product , problem, and actions to be taken by the customers. Siemens recommends that customers reestablish their own medians and reference ranges, in line with the recommendations made in the IFU for these products. A Field Correction Effectiveness Check form was included for customers to complete and return to the firm. Customers with questions or who need additional information should contact their Siemens Technical Solutions Center.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JHX
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-01-25
- Date posted
- 2012-03-21
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (K034055) | Diagnostic Products Corp. | 2004-01-21 |