Company:Beckman Coulter Inc.
Date of Enforcement Report 4/18/2018
Class lI:
PRODUCT
AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
Recall Number Z-1341-2018
REASON
The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification..
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea CA on 1/29/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
288 devices
DISTRIBUTION
Nationwide and Internationally
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