Food, drugs, devices › Beckman Coulter Inc.
Device recall: iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter
FDA enforcement event 82879 is a device recall by Beckman Coulter Inc. of Brea, CA, initiated 18 Oct 2018 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 10 Nov 2020. 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., Brea, CA.
Reason for recall
"Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction."
Distribution
"Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1937-2019 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany. | 956,798/100 test strip vials | Class II | Terminated | 10 Jul 2019 |
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: "Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction."
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 was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Nov 2020. "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.