Z-2350-2015Class II

PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification...

Name: Z-2350-2015 PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification...
Creator: Remel Inc
Published: 2015-06-30
License: https://open.fda.gov/license/

Remel Inc / initiated 2015-06-30 / Terminated

FDA source

Remel Inc began a recall of PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield... on 2015-06-30. FDA classified it as Class II and gives the reason as "A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2350-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-30
Posted: 2015-08-07
Terminated: 2017-02-13
Recalling firm: Remel Inc
Product: PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
Product code: GTY Antigens, All Groups, Streptococcus Spp.
Reason for recall: A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 1859 kits
Distribution: Nationwide Distribution, including Puerto Rico and the country of Canada.
Product codes and lots: lot 1470133, exp. date 31 Mar 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2350-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2350-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-07
Z-2351-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-07

Product code GTY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)