Recall Z-1891-2010 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics Inc.
IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.
| Date | Jun 24, 2010 (initiated May 15, 2009) |
| Status | Terminated |
| Reason | These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods. |
| Root cause | Device Design |
| Action | An Urgent Field Safety Notice dated May 2009 was sent to consignees of record for the previously mentioned lots. The Notice advised the following: These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods. Actions If you are using one of these lots with your instrument, please take the following actions: 1. Upon receipt of a non-affected substrate lot, discontinue using IMMULITE 2000/2500 Chemiluminescent Substrate. Prior to receiving a non-affected substrate lot, you can continue to use the affected substrate if you follow t |
| Quantity | 41,573 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER Dpc Cirrus, Apr 8, 1997 |