Class II — HemoCue AB
| Recalling firm | HemoCue AB |
|---|---|
| Registered facility | HEMOCUE AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | HemoCue AB has become aware of a production related problem involving punctured HemoCue® Urine Albumin Microcuvettes single pack pouches. |
| Product | HemoCue® Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue U… |
| Quantity | 10,356 boxes/50 microcuvettes |
| Distribution | Worldwide Distribution - Nationwide Distribution including the states of AL, AR, AZ, CA, CA ,CT, FL, GA, HE, ID, IL, IN, LA, MA, ME, MI, MN, MO, MS, NC, NH, NM, NY, OH, PA, SC,TX, UT, VA, VT, WA and WI., and the countries of Australia, Bahrain, Belarus, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Indonesia, Italy, Kenya, Lesotho, Malawi, Mauritius,… |
| Initiated | 2013-07-16 |
| Classified | 2013-10-25 |
| Terminated | 2014-04-28 |
| Recall number | Z-0086-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — HemoCue AB (Z-0086-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65918/
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