Z-0619-2013Class III

Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette...

Name: Z-0619-2013 Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette...
Creator: HemoCue AB
Published: 2012-11-07
License: https://open.fda.gov/license/

HemoCue AB / initiated 2012-11-07 / Terminated / root cause: labeling and UDI

FDA source

HemoCue AB began a recall of Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The... on 2012-11-07. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0619-2013
Classification: Class III
Status: Terminated
Initiated: 2012-11-07
Posted: 2012-12-28
Terminated: 2013-03-14
Recalling firm: HemoCue AB
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.
Product code: JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: HemoCue sent an "IMPORTANT MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Correction Notification Verification Form was included for customers to complete and return. Contact the firm at 562-668-5741 for questions regarding this notification.
Quantity in commerce: 48 affected analyzers
Distribution: Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
Product codes and lots: See serial numbers of affected devices in attachment profided by firm.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0619-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0619-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-09	2012-12-28

Product code JIQ

K053253Class IHemocue Albumin 201 Analyzing SystemHemocue AB / cleared 2006-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)