Beckman Coulter Reagents (2017-04-03)

Starting date:

April 3, 2017

Posting date:

May 2, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-63124

• Reason
• Affected products

Affected Products

1. Uric Acid Reagent (Uric)
2. Triglycerides Reagent (Tg And Tg-B)
3. Cholesterol Reagent (Chol)
4. HDL Cholesterol Reagent (HDL)
5. Enzymatic Creatinine Reagent (Cr-E)
6. Lactate Reagent (Lact)
7. Salicylate Reagent (Saly)

Reason

Beckman Coulter has identified the following drugs as potential sources of interference:
Metamizole (dipyrone) - analgesic/antispasmodic/antipyretic (note: no longer approved for sale in certain geographies, including the US and Canada), may generate false low cholesterol, enzymatic creatinine, HDL cholesterol, lactate, triglycerides and uric acid results.
Sulfasalzine - anti-inflammatory, may generate false high salicylic results.
Sulfapyridine - sulfonamide antibiotic, may generate false low salicylic results.

Affected products