FDA Device recall Z-0619-2013
Analyzing system consists of a small and portable analyzer and plastic microcuvettes
- FDA Device
- Class III
- terminated
- Published 2013-01-09
On 2013-01-09 the FDA classified a Class III recall of Analyzing system consists of a small and portable analyzer and plastic microcuvettes by Hemocue Ab, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0619-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-11-07 |
| Published | 2013-01-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hemocue Ab |
| Distribution | CA, FL, GA, ID, IL, IN, KS, KY, MA, MO, NC, NY, OK, OR, PA, TX, UT |
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
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.
Identifiers
| code_info | See serial numbers of affected devices in attachment profided by firm. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0619-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.