FDA (Devices) recall action 82683
The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 106 days. The expiration date is being shortened to 105 days.
Remel Inc is recalling Thio Med culture media because the product may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.
Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is shortened from 9 months to 105 days.
Remel Inc is recalling 27 units of Thio Med w/o Ind, w/Dex due to potential failure in performance testing after 106 days.
Remel Inc is recalling Thio Med culture media due to potential failure to meet performance standards after 106 days from manufacturing.
Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.
Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because products may fail performance testing after 106 days from manufacturing.
Remel Inc is recalling 1,069 units of Thio Med w/Dex, Hem, Vit K media due to potential performance failures after 106 days.
Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is being shortened to 105 days.
Remel Inc is recalling Thio Med culture media due to potential performance failures after 106 days. The expiration date is shortened to 105 days.