Recall Z-3135-2017 ยท OYE Flow Cytometric Reagents And Accessories.
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
| Date | Aug 21, 2017 |
| Status | Terminated |
| Reason | Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples. |
| Root cause | Under Investigation by firm |
| Action | The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 16, 2017 to the affected customers via email, mail, and phone during the week of August 21, 2017. The letter described the product, problem and actions to be taken. The customers are instructed to follow instructions provided in the letter and complete and return the Customer Response Form within 10 days via Fax to: (786)-639-7500 /7501 /7502 /7504; mail to: Beckman Coulter, Inc.,- Attn: Regulatory Affairs Mail Code 31-B06; 11800 S.W. 147th Avenue; P O BOX 169015, Miami, FL 33116-9015 or email (if received el |
| Quantity | 213 units (34 units in the US) |
| Distribution | Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141932 | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS Beckman Coulter, Inc., Apr 10, 2015 |