Z-1500-2020 Class II Terminated
FDA device recall Z-1500-2020 was initiated by The Binding Site Group, Ltd. on November 6, 2019 and is designated Class II. Reason for recall: 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 ma… The recall status is terminated (terminated September 8, 2022). Affected quantity: 30 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- November 6, 2019
- Termination Date
- September 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 kits
Product Description
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Reason for Recall
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.
Distribution Pattern
Distributed in CA.
Code Information
Lot 428217 (Expiry date: 30-APR-2020