Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 18, 2013
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
HemoCue Ab recalled HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The Hemo… - a moderate-severity action.
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The Hemo… was recalled by HemoCue Ab in September 18, 2013. Reason: During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.. Check the official notice for the remedy. Verify recall #Z-2190-2013 with the FDA Devices before acting.
The recall
HemoCue Ab issued this moderate-severity FDA Devices recall-During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches..
- Moderate
- severity level
- Class II
- classification
- September 18, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2190-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2190-2013) was formally reported on September 18, 2013, with the manufacturer initiating the action on July 15, 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 22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US.
The documented reason for this recall is: During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLANDS, NEW ZEALAND, NOR…. 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
22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US
Related Recalls
6
3 from same agency
Product description
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
Reason for recall
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2190-2013 |
| Date reported | September 18, 2013 |
| Date initiated | July 15, 2013 |
| Recalling firm | HemoCue Ab |
| Firm location | Angelholm, N/A |
| Affected scope | 22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, Q… |
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-2190-2013) 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¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.. Recalled by HemoCue Ab. Units affected: 22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US.
Why was this product recalled? ▼
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2013. Severity: Moderate. Recall number: Z-2190-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIAN FEDERATION, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, VIET NAM & YEMEN. ..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2190-2013) 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 September 18, 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.