Recall Z-1327-2020— The Binding Site Group, Ltd.

Name: FDA recall Z-1327-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-29

Class II · Terminated

Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2019-07-29, terminated 2022-01-13. It names 2 FDA 510(k) clearances: K191635, K191465. Product: OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565. Reason: There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed..

Recalling firm: The Binding Site Group, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2019-07-29
Terminated: 2022-01-13
Firm location: Birmingham, United Kingdom

510(k) clearances named in this recall

2 on FDA's record

K191635 — Optilite IgM KitThe Binding Site Group , Ltd.·cleared 2019-07-15
K191465 — Human IgM Kit for use on SPAPlusThe Binding Site Group , Ltd.·cleared 2019-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

Reason for recall

There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.