Recall Z-2084-2017
Beckman Coulter Inc. · initiated April 3, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.
Codes / lots: all lots
Reason for recall
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
FDA-determined cause: Under Investigation by firm
Action taken
An Urgent Medical Device Recall letter dated 4/3/17 was sent to customers to inform them that Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole, Sulfasalazine, and Sulfapyridine. Customers are informed that with the administration of these drugs, the effects to patient analytes are: - Metamizole (Dipyrone) may generate false low Cholesterol, Enzymatic Creatinine, HDL Cholesterol, Lactate, Triglycerides and Uric Acid results. -Sulfasalazine may generate false high Salicylate results. -Sulfapyridine may generate false low Salicylate results. Customers are informed of the action and resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center -Via http://www.beckmancoulter.com/customersupport/support -Via phone, call 1-800-854-3633 in the United States and Canada Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Details
- Recall number
- Z-2084-2017
- Initiated
- April 3, 2017
- Terminated
- May 31, 2018
- Product code
- DKJ – Colorimetry, Salicylate
- Quantity
- 50,645 units total (43,816 units in US)
- Distribution
- Worldwide Distribution -- Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar…
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2078-2017 Class II | Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative…Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole… | 04/03/2017Terminated |
| Z-2079-2017 Class II | Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative…Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole… | 04/03/2017Terminated |
| Z-2080-2017 Class II | Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the…Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole… | 04/03/2017Terminated |
| Z-2081-2017 Class II | Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative…Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole… | 04/03/2017Terminated |
| Z-2082-2017 Class II | HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative…Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole… | 04/03/2017Terminated |
| Z-2083-2017 Class II | Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative…Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole… | 04/03/2017Terminated |