Recall Z-0069-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
| Date | Oct 19, 2011 (initiated Aug 31, 2011) |
| Status | Terminated |
| Reason | Firm has confirmed customer complaints for low recovery of QC and patient samples. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 6,072 cartons |
| Distribution | Worldwide distribution: USA, Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, Spain and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081643 | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 Siemens Healthcare Diagnostics, Jul 3, 2008 |