Food, drugs, devices › Beckman Coulter Inc.
Device recall: Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determina
FDA enforcement event 73921 is a device recall by Beckman Coulter Inc. of Brea, CA, initiated 13 Apr 2016 and classified Class II, with 5 product records.
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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 30 Jun 2016. 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
"Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30."
Distribution
"Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1930-2016 | Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers. | 32,926 units total (6,041 units in US) | Class II | Terminated | 15 Jun 2016 |
| Z-1931-2016 | Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers. | 54,351 units total (31,612 units in US) | Class II | Terminated | 15 Jun 2016 |
| Z-1932-2016 | Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers. | 59,401 units total (10,868 units in US) | Class II | Terminated | 15 Jun 2016 |
| Z-1933-2016 | Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers. | 43,877 units total (10,496 units in US) | Class II | Terminated | 15 Jun 2016 |
| Z-1934-2016 | Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers. | 79,009 units total (21,215 units in US) | Class II | Terminated | 15 Jun 2016 |
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: "Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30."
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: "Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Jun 2016. "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.