Reported Feb 13, 2013 · Terminated
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain…
Hitachi Chemical Diagnostics Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi Chemical Diagnostics Inc · 630 Clyde Ct · Mountain View, CA · 94043-2239
Is this the product you have?
- OPTIGEN Food 30
- Catalog number85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
- Lot codes and dates
- Catalog number
85035. Lot number 42K283626expiration May 312013
- Catalog number
- Amount recalled
- 20 kits
Why it was recalled
There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Hitachi Chemical Diagnostics Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.