Reported Feb 12, 2014 · Terminated
ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting…
Horiba Instruments, Inc. dba Horiba Medical
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Horiba Instruments, Inc dba Horiba Medical · 34 Bunsen · Irvine, CA · 92618-4210
Is this the product you have?
- ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
- Lot codes and dates
- Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701
- Shelf LifeLot#s 1207001 & 1300701
- Expire on06/30/2014. Lot# 1303601
- Expires on09/30/2014
- Amount recalled
- 531
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to include revised acceptable Target Ranges for Creatinine.No other analyte values are affected.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Horiba Instruments, Inc. dba Horiba Medical recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.