FDA Devices recall · Reported November 6, 2013
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 usi
HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches.
HemoCue Ab recalled HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden Th… - a moderate-severity action.
HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden Th… was recalled by HemoCue Ab in November 6, 2013. Reason: HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microc…. Check the official notice for the remedy. Verify recall #Z-0086-2014 with the FDA Devices before acting.
The recall
HemoCue Ab issued this moderate-severity FDA Devices recall-HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microc….
- Moderate
- severity level
- Class II
- classification
- November 6, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0086-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes
Reason for recall
HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0086-2014 |
| Date reported | November 6, 2013 |
| Date initiated | July 16, 2013 |
| Recalling firm | HemoCue Ab |
| Firm location | Angelholm, N/A |
| Affected scope | 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, B… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0086-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026