Food, drugs, devices › Beckman Coulter, Inc.
Device recall: iChemVELOCITY Strips, Catalog 800-7212
FDA enforcement event 85047 is a device recall by Beckman Coulter, Inc. of Miami, FL, initiated 17 Feb 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 13 May 2021. Initiation: voluntary: firm initiated. Beckman Coulter, Inc. has 216 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Beckman Coulter, Inc., Miami, FL.
Reason for recall
"The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips."
Distribution
"Distribution in US including Puerto Rico, Canada, and Taiwan"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1535-2020 | iChemVELOCITY Strips, Catalog 800-7212 | 10822 vials | Class II | Terminated | 1 Apr 2020 |
Context
Other enforcement events for Beckman Coulter, Inc.
All 216 events for Beckman Coulter, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution in US including Puerto Rico, Canada, and Taiwan"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 May 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.