Recall Z-2079-2017— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-04-03, terminated 2018-05-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.. Reason: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-03
- Terminated
- 2018-05-31
- Firm location
- Brea, CA, United States
Product description
Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.
Reason for recall
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.