Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1043-2017 — Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

U.S. FDA — Device Enforcement · United Kingdom · 2016-07-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1043-2017
Date of alert
2016-07-05
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
The Binding Site Group, Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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