Recall Z-0649-2016— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2014-12-08, terminated 2016-01-13. It names one FDA 510(k) clearance: K060280. Product: iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.. Reason: Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-08
- Terminated
- 2016-01-13
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
Reason for recall
Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
Data sourced from openFDA. This site is unofficial and independent of the FDA.