Recall Z-0619-2013 ยท JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
HemoCue AB
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 turbidit
| Date | Dec 28, 2012 (initiated Nov 7, 2012) |
| Status | Terminated |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053253 | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM Hemocue AB, Feb 17, 2006 |