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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANDOX LABORATORIES LTD LIQUID CARDIAC CONTROL LEVEL 2

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RANDOX LABORATORIES LTD LIQUID CARDIAC CONTROL LEVEL 2 Back to Search Results
Catalog Number CQ5052
Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Randox has previously issued a recall for liquid cardiac control level 3 cq5053 lot 4245ck under rec334 (fda reference number z-2575-2018) on the 08 june 2018. Under this investigation all lots were evaluated for vial to vial imprecision and all met acceptance criteria. Subsequently, a customer queried the recovery of troponin t in liquid cardiac control level 2 cq5052 lot 4244ck. The deviation in precision observed is up to 12%. While this has been determined as acceptable by randox in the previous investigation it is not meeting the customer's needs. During the investigation of the customer complaint, real time data became available which indicated that the median recovered value has shifted from target. While the analyte median value is recovering in range this indicated a further issue with the product. Variation or a decrease in recovery of troponin t in a quality control material could delay reporting of results to a clinician. A delay in reporting troponin t could result in a delay in confirmatory diagnosis of myocardial infarction. This delay could result in a delay in treatment of the patient. Given recent complaints about this analyte and the critical nature in diagnosing cardiac events, a decision has been made to remove the claims for this analyte permanently.
 
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Brand NameLIQUID CARDIAC CONTROL LEVEL 2
Type of DeviceLIQUID CARDIAC CONTROL LEVEL 2
Manufacturer (Section D)
RANDOX LABORATORIES LTD
55 diamond road
crumlin, northern ireland BT29 4QY
UK BT29 4QY
Manufacturer (Section G)
RANDOX LABORATORIES LTD
55 diamond road
crumlin, northern ireland BT29 4QY
UK BT29 4QY
Manufacturer Contact
maria kelly
55 diamond road
crumlin, BT29 -4QY
UK   BT29 4QY
MDR Report Key7929582
MDR Text Key123383355
Report Number8020890-2018-00003
Device Sequence Number0
Product Code JJY
PMA/PMN Number
K110534
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Relabeling
Type of Report Initial
Report Date 09/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCQ5052
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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