Recall Z-2636-2017— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-05-09, terminated 2018-03-30. It names 2 FDA 510(k) clearances: K031269, K002905. Product: Access Thyroglobulin, A34085G, Catalog No. 33860. Reason: The Access immunoassays are susceptible to biotin interference..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-09
- Terminated
- 2018-03-30
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K031269 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K002905 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
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
Access Thyroglobulin, A34085G, Catalog No. 33860
Reason for recall
The Access immunoassays are susceptible to biotin interference.
Data sourced from openFDA. This site is unofficial and independent of the FDA.