Recall Z-1700-2012 ยท CFP Radioimmunoassay, Immunoreactive Insulin
Siemens Healthcare Diagnostics
IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test Code: INS, Color: Orange Product Usage: For in vitro diagnostic use with IMMULITE and IMMULITE 1000 Systems Analyzers --- for the quantitative measurement of insulin in serum or heparinized plasma, for the management of diabetes.
| Date | Jun 2, 2012 (initiated Apr 30, 2012) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay. |
| Root cause | Component change control |
| Action | Siemens sent an Urgent Device Recall letter dated April 2012 via fax to affected U.S. customers and an Urgent Field Safety Notice to customers outside the U.S. The letter identified the affected kit lots, reason for voluntary recall, risk to health and actions to be taken by the customer/user. Customers were instructed to discard any inventory of the affected kit lots and complete and return the attached Field Correction Effectiveness Check questionnaire within thirty (30) days to request a no-charge replacement kits. Customers were requested to post this field correction by each IMMULITE s |
| Distribution | Worldwide Distribution - US (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER Diagnostic Products Corp., Aug 21, 2002 |