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Terminated

Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings

FDA Recall Z-0553-2018 · Posted None

Recalling FirmThe Binding Site Group, Ltd.
Recall StatusTerminated
Product CodeDHR
Date Initiated2018-01-04
Date Terminated2020-06-09
Product Quantity49 kits to the U.S. office (32 kits further distributed)

Reason for Recall

The low and high controls for the product are returning results above the assigned values.

Firm Action

Binding Site sent an Urgent Field Safety Notice dated December 22, 2017. Advise on action to be taken by the User: " The new QC values detailed below should be used for the remainder of the shelf life of this Rheumatoid Factor Kit for use on SPAPLUS. "Input the revised QC values into your SPAPLUS instrument "Sign and return the TSWS18 E-Back Form accompanying this notification within 5 business days "Refer to Section 9 of the Product Insert SIN282(.A) if QCs are out of range following reassignment. For further questions, please call (858) 453-9177.

Root Cause

Under Investigation by firm

Distribution Pattern

US Distribution was made to CA. There was no foreign/military/government distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd. · 2016-12-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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