Recalls / —
—#103939
Product
Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
- FDA product code
- JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K081643
- Affected lot / code info
- Lot Numbers ED2098, EA2111, FB2134, ED2147
Why it was recalled
Firm has confirmed customer complaints for low recovery of QC and patient samples.
Root cause (FDA determination)
Process control
Action the firm took
Siemens Healthcare Diagnostics, Inc. Urgent Field Safety Notice was sent to customers on August 31, 2011 regarding the issue. The letter instructs customers to immediately discontinue use of the affected lots and discard all remaining inventory.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466
Distribution
- Distribution pattern
- Worldwide distribution: USA, Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, Spain and Switzerland.
Timeline
- Recall initiated
- 2011-08-31
- Posted by FDA
- 2011-10-19
- Terminated
- 2014-01-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #103939. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.