Recall Z-2768-2015 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
MedtestDx, Inc.
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
| Date | Sep 15, 2015 (initiated May 15, 2015) |
| Status | Terminated |
| Reason | Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end. |
| Root cause | Process design |
| Action | On 5/15/2015, MedTest DX Field Correction Notice notifications were sent to the affected customers via electronic mail and US mail. 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. Any questions concerning the corrective action may be directed to MedTest Technical Service Department at 1-800-757-5313. |
| Quantity | 79 kits |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942458 | PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED Randox Laboratories, Ltd., Mar 13, 1995 |