PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-he
FDA device recall Z-2350-2015 · posted 2015-08-07 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
- Action taken
- On 4/28/2015, the recalling firm's European subsidiary notified the recalling firm of the recall. On 6/30/2015, the recalling firm notified their customers of the recall via letter, sent USPS standard mail.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GTY
- Quantity affected
- 1859 kits
- Distribution
- Nationwide Distribution, including Puerto Rico and the country of Canada.
- Date initiated
- 2015-06-30
- Date posted
- 2015-08-07
- Date terminated
- 2017-02-13
- Location
- Lenexa, KS
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