Recall Z-2167-2017— Randox Laboratories

Name: FDA recall Z-2167-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-27

Class III · Terminated

Class III FDA medical device recall by Randox Laboratories, initiated 2017-04-27, terminated 2017-08-14. It names one FDA 510(k) clearance: K110904. Product: Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.. Reason: According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice.

Recalling firm: Randox Laboratories
Classification: Class III
Status: Terminated
Initiated: 2017-04-27
Terminated: 2017-08-14
Firm location: Kearneysville, WV, United States

510(k) clearances named in this recall

1 on FDA's record

K110904 — RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3Randox Laboratories, Ltd.·cleared 2011-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.

Reason for recall

According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice

Data sourced from openFDA. This site is unofficial and independent of the FDA.