Recall Z-2841-2016 ยท CFL Radioimmunoassay, Human Growth Hormone
Siemens Healthcare Diagnostics, Inc.
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
| Date | Sep 16, 2016 (initiated Apr 15, 2016) |
| Status | Terminated |
| Reason | 24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit. |
| Root cause | Unknown/Undetermined by firm |
| Action | On April 15, 2016, Siemens Healthcare Diagnostics Inc. distributed Urgent Medical Device Correction notices to their domestic customers and Urgent Field Safety Notices to their internationally customers via courier service. Customers are advised to take the following four actions: 1) To continue using IGF-I kit lot 411 and the associated pretreatment solution lot 055 to report patient results, ensure the IGF-I pretreatment solution is allowed to incubate with the patient sample for a minimum of 24 minutes prior to processing on the IMMULITE/IMMULITE 1000 systems. 2) Complete and return the E |
| Quantity | 525 units |
| Distribution | Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.