OPTIGEN Food 30 Allergen Testing Kits Recalled for Potential False Negatives
Hitachi Chemical Diagnostics is recalling 20 kits of OPTIGEN Food 30 allergen testing products due to a potential low fill volume that could cause false negative results.
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 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 III, which is typically associated with low severity (1 or 2) as it is unlikely to cause adverse health consequences. The hazard is a potential for false negative results rather than a direct physical injury or contamination.
Plain-English summary
Hitachi Chemical Diagnostics Inc is recalling 20 kits of OPTIGEN Food 30 (Catalog number: 85035) used for allergen testing. The affected product is Lot number 42K283626, with an expiration date of May 31, 2013. The product was manufactured by Hitachi Chemical Diagnostics in Mountain View, CA, and distributed by Theridiag in Cedex, France.
The recall was initiated because there is no evidence that a visual inspection was performed on one tray of coverslips. This oversight creates a possibility of low fill volume, which could lead to false negative results in allergen testing.
The distribution pattern is listed as worldwide distribution, specifically France only. Users of this product should stop using the affected kits and contact the recalling firm for further instructions.
The recalled product
- Product
- OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
- Manufacturer
- Hitachi Chemical Diagnostics Inc
- Hazard
- Affected units
- 20
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 (3)
- Catalog number: 85035. Lot number 42K283626
- expiration May 31
- 2013.
Distribution
Distribution scope not specified by the agency.
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