Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Reported: March 25, 2020 Initiated: November 6, 2019 #Z-1500-2020
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.
Details
- Recalling Firm
- The Binding Site Group, Ltd.
- Units Affected
- 30 kits
- Distribution
- Distributed in CA.
- Location
- Birmingham
Frequently Asked Questions
What product was recalled? ▼
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319. Recalled by The Binding Site Group, Ltd.. Units affected: 30 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1500-2020.
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