MedTest DX Assayed Human Multi Sera Control Recall for Out-of-Spec Values
Medtest Holdings, Inc. is recalling MedTest DX Assayed Human Multi Sera Control Level 1 and Level 2 because control values are outside of specification.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a quality control specification failure rather than a direct safety hazard like contamination or injury.
Plain-English summary
Medtest Holdings, Inc. is recalling MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200). The recall was initiated because the control values for these products are outside of specification.
The affected products are lyophilized human-based control sera used for the quality control of diagnostic assays. They are available in two concentration levels: normal (HNC) and elevated (HEC). The recall covers 10,260 vials distributed nationwide in the United States.
No specific illnesses or injuries have been reported in the source text. Users of these products should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green…
- Manufacturer
- Medtest Holdings, Inc.
- Hazard
- Affected units
- 10,260
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 (10)
- HEC200: " 616UE
- Mfr. Date 2013-02
- Exp. 2017-01 " 652UE
- Mfr. Date 2013-07
- Exp. 2017-07 " 720UE
- Mfr. Date 2014-08
- Exp. 2018-07 HNC200: " 858UN
- Exp. 2018-07 " 941 UN
- Mfr. Date 2014-07
- Exp. 2018-06
Distribution
Distributed nationwide across the United States.
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