Analyzing system consists of a small and portable analyzer and… — Class III medical device recall Z-0619-2013
Terminated recall by HemoCue AB, reported 2013-01-09, distributed in CA, FL, GA, ID, IL, IN, KS, KY…. Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2
| Recall number | Z-0619-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HemoCue AB, Angelholm, N/A, Sweden |
| Recall initiated | 2012-11-07 |
| Classified | 2012-12-28 |
| Reported by FDA | 2013-01-09 |
| Terminated | 2013-03-14 |
| Distributed | CA, FL, GA, ID, IL, IN, KS, KY, MA, MO, NC, NY, OK, OR, PA, TX, UT |
| Quantity | 48 affected |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0619-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.