Recall Z-2631-2017— Medtest Holdings, Inc.

Name: FDA recall Z-2631-2017
Creator: U.S. Food and Drug Administration
Published: 2009-07-21

Class III · Terminated

Class III FDA medical device recall by Medtest Holdings, Inc., initiated 2009-07-21, terminated 2017-07-24. It names one FDA 510(k) clearance: K030545. Product: Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. Reason: Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L..

Recalling firm: Medtest Holdings, Inc.
Classification: Class III
Status: Terminated
Initiated: 2009-07-21
Terminated: 2017-07-24
Firm location: Canton, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K030545 — CRP-LATEX (II)X2 SEIKEN ASSAY KITDenka Seiken Co., Ltd.·cleared 2003-06-02

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

Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only

Reason for recall

Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.

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