Medtest Holdings, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2063-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.

Product Classification:

Class II

Date Initiated: April 3, 2015

Date Posted: July 6, 2016

Recall Number: Z-2063-2016

Event ID: 74234

Reason for Recall:

Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.

Status: Terminated

Product Quantity: 13

Code Information:

Model: H7575-57 Lot: 416703 Expiration date: 2016-01

Distribution Pattern:

MI, MN, NJ, IL, NY. US Only.

Voluntary or Mandated:

Voluntary: Firm initiated