Recall Z-1366-2018— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-11-10, terminated 2022-12-21. It names one FDA 510(k) clearance: K022774. Product: iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157. Reason: iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-10
- Terminated
- 2022-12-21
- 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
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
Reason for recall
iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria.
Data sourced from openFDA. This site is unofficial and independent of the FDA.