Severity
Moderate
ModerateClass IITerminated
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0086-2014) was formally reported on November 6, 2013, with the manufacturer initiating the action on July 16, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. HemoCue Ab is listed as the recalling firm, operating out of Angelholm, N/A. Federal records list the affected scope as 10,356 boxes/50 microcuvettes.
The documented reason for this recall is: HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches. Distribution data in the federal record shows the product reached: 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 countr…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
10,356 boxes/50 microcuvettes
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by HemoCue Ab. Units affected: 10,356 boxes/50 microcuvettes.
Why was this product recalled? ▼
HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0086-2014.
Where was the recalled product distributed? ▼
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, Mexico, Myanmar, Nigeria, Norway, Omen, Poland, Qatar, Romania, South Africa, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Ukraine, Yemen and Zambia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0086-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 6, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.