Recall Z-2316-2017— Medtest Holdings, Inc.

Name: FDA recall Z-2316-2017
Creator: U.S. Food and Drug Administration
Published: 2014-10-23

Class III · Terminated

Class III FDA medical device recall by Medtest Holdings, Inc., initiated 2014-10-23, terminated 2017-11-17. It names one FDA 510(k) clearance: K942458. Product: MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).. Reason: MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification..

Recalling firm: Medtest Holdings, Inc.
Classification: Class III
Status: Terminated
Initiated: 2014-10-23
Terminated: 2017-11-17
Firm location: Canton, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K942458 — PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATEDRandox Laboratories, Ltd.·cleared 1995-03-13

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

MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).

Reason for recall

MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.

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