Food, drugs, devices › Beckman Coulter Inc.
Device recall: Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
FDA enforcement event 70030 is a device recall by Beckman Coulter Inc. of Brea, CA, initiated 15 Dec 2014 and classified Class II, with 4 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 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 19 Feb 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
"N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results."
Distribution
"Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1023-2015 | Beckman Coulter, Lipase Assay, Catalog No. OSR6X30 | 75,959 units total (31,233 units in US) | Class II | Terminated | 4 Feb 2015 |
| Z-1024-2015 | Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 | 32,159 units total (10,462 units in US) | Class II | Terminated | 4 Feb 2015 |
| Z-1025-2015 | Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16 | 59,965 units total (21,782 units in US) | Class II | Terminated | 4 Feb 2015 |
| Z-1026-2015 | Beckman Coulter, Lactate Assay, Catalog No. OSR6X93 | 31,799 units total (15,841 units in US) | Class II | Terminated | 4 Feb 2015 |
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: "N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results."
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: "Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Feb 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.