Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System The ECREA method is
FDA device recall Z-2154-2011 · posted 2011-05-09 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.
- Action taken
- Siemens sent an Urgent Field Safety Notice letter dated June 2010 to all Dimension Vista(R) ECREA customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to: Discontinue use of ECREA method and transition to the Dimension(R) Jaffe creatinine (CREA) method. To notify anyone to whom they may have distributed the product. Complete and return the Effectiveness Check Questionnaire attached to the letter by fax to (302) 631-8467. For questions regarding this recall call (302) 631-6299.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 1,399
- Distribution
- Nationwide Distribution - including AL, AZ, CA, CO, DE, FL, GA, ID, IL, IA, MD, MA, MI, MT, NH, NJ, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI.
- Date initiated
- 2010-06-10
- Date posted
- 2011-05-09
- Date terminated
- 2013-12-19
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 (K090330) | Siemens Healthcare Diagnostics, Inc. | 2009-05-22 |