Z-2768-2015 Class II Terminated
FDA device recall Z-2768-2015 was initiated by MedtestDx, Inc. on May 15, 2015 and is designated Class II. Reason for recall: 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 rang… The recall status is terminated (terminated May 23, 2016). Affected quantity: 79 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2015
- Initiation Date
- May 15, 2015
- Termination Date
- May 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79 kits
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution.
Code Information
Catalog number: HC-DIL Lot: 072414-206 Expiration date: 2016-07