Recall Z-0152-2014— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2013-09-09, terminated 2014-09-30. It names 4 FDA 510(k) clearances: K011720, K003721, K981743 and 1 more. Product: ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.. Reason: The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-09
- Terminated
- 2014-09-30
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
4 on FDA's record- K011720 — OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
- K003721 — MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
- K981743 — OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
- K961274 — OLYMPUS AU600 CLINICAL CHEMISTRY 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
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Reason for recall
The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.