MedTest DX Control Reconstitution Fluid Recalled for Fill Volume Variation
MedtestDx, Inc. is recalling 79 kits of MedTest DX Control Reconstitution Fluid due to vial fill volume variations that may cause control results to fall outside suggested ranges.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic errors due to fill volume variation, but no injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
MedtestDx, Inc. is recalling 79 kits of MedTest DX Control Reconstitution Fluid (Catalog number: HC-DIL, Lot: 072414-206, Expiration date: 2016-07). The product is an in vitro diagnostic reagent used to reconstitute Human controls HNC200 and HEC200. The kits were distributed nationwide in the United States.
The recall was initiated because of vial-to-vial variation in the fill volume. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute the controls, this variation caused control values to be out of range, specifically running on the high end, which could affect control recovery issues.
Users of the product should stop using the affected lots and contact MedtestDx, Inc. for further instructions or a replacement.
The recalled product
- Product
- 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…
- Manufacturer
- MedtestDx, Inc.
- Affected units
- 79
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog number: HC-DIL Lot: 072414-206 Expiration date: 2016-07
Distribution
Distributed nationwide across the United States.
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