Recall Z-1043-2017 ยท DEH Lambda, Antigen, Antiserum, Control
The Binding Site Group, Ltd.
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
| Date | Jan 18, 2017 (initiated Jul 5, 2016) |
| Status | Terminated |
| Reason | Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards. |
| Root cause | Under Investigation by firm |
| Action | On 07/05/16 notification letters were sent to customers. The Binding Site Group requests the following: - Immediately Quarantine & Dispose of any LK018.OPT lot 405566 kits within stock; - Remove any affected lots from the Optilite instrument; - Patients with Lambda Freelite results >114mg/L should be reviewed in consultation with clinicians, alongside other clinical findings and retested where applicable; - Notify local Binding Site representative to request replacement kits; - Return completed E-Back Form to local Binding Site Representative; The firm recommended that the notice be circu |
| Quantity | 809 kits |
| Distribution | U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA. Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit The Binding Site Group , Ltd., Aug 26, 2015 |