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Recall Observatory FDA recall evidence

Device product

Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319

Z-1500-2020

November 06, 2019

Class II

Product summary

Firm
The Binding Site Group, Ltd.
Event
Event 84909
Status
Terminated
Classification
Class II
Quantity
30 kits
Official record key
device-enforcement:Z-1500-2020

Official wording

Reason: It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.

Code information: Lot 428217 (Expiry date: 30-APR-2020

Distribution pattern: Distributed in CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.