Recall Z-2063-2016 ยท LPS Urinary Homocystine (Nonquantitative) Test System
Medtest Holdings, Inc.
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.
| Date | Apr 3, 2015 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Unknown/Undetermined by firm |
| Action | On 4/3/2015, Urgent Field Safety Notice notifications were sent to the affected customers via email with instructions for identifying and destroying the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. |
| Quantity | 13 |
| Distribution | MI, MN, NJ, IL, NY. US Only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 Axis-Shield Diagnostics, Ltd., Jul 31, 2009 |