CLASS III Device recall · Reported 9 Jan 2013 · FDA Enforcement Report
Analyzing system consists of a small recalled by HemoCue AB
HemoCue AB is recalling Analyzing system consists of a small and portable analyzer and plastic microcuvettes, distributed in 17 states. The recall was initiated on 7 Nov 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0619-2013
- FDA event ID
- 63825
- Recalling firm
- HemoCue AB, Angelholm, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Nov 2012
- FDA classified
- 28 Dec 2012
- Reported
- 9 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Patient Monitors
Timeline
| 7 Nov 2012 | Recall initiated by company | |
| 28 Dec 2012 | Classified by FDA | +51 days |
| 9 Jan 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. 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.
Where it was distributed
Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
CaliforniaFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyMassachusettsMissouriNorth CarolinaNew YorkOklahomaOregonPennsylvaniaTexasUtah
Questions about this recall
Why was it recalled?
Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.
Which lots are affected?
See serial numbers of affected devices in attachment profided by firm.
Where was it sold?
Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from HemoCue AB
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The HemoCue Glucose 201 Microcuvettes are designed recalled | HemoCue AB | Potency & Assay | Nationwide |
| Device | CLASS II | HemoCue¿ Hb 201 Microcuvettes recalled by HemoCue AB | HemoCue AB | Other | 38 states |
| Device | CLASS II | HemoCue¿ Urine Albumin Microcuvettes recalled by HemoCue AB | HemoCue AB | Potency & Assay | Nationwide |
| Device | CLASS II | HemoCue¿ Glucose 201 Microcuvettes recalled by HemoCue AB | HemoCue AB | Packaging Defects | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |