Recalls / —
—#152701
Product
The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension clinical chemistry system. For prescription use only.
- FDA product code
- JIT — Calibrator, Secondary
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K103836
- Affected lot / code info
- Product Lot: 4MD047, 5CD052, 5FD017, 5GD050, 5HD010, 5JD069, 5LD051, 6AD054
Why it was recalled
Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Siemens mailed an Urgent Medical Device Notification letter to all affected customers on May 10, 2016. The notice provided information on actions to be taken by the customer to work around the issue. For further questions, please call (800) 441-9250.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466
Distribution
- Distribution pattern
- Distributed throughout the United States
Timeline
- Recall initiated
- 2016-05-05
- Terminated
- 2018-02-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #152701. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.