CLASS II Device recall · Reported 19 Aug 2015 · FDA Enforcement Report

PathoDx Strep Grouping Kit recalled by Remel

Remel is recalling PathoDx Strep Grouping Kit, distributed nationwide in the US. The recall was initiated on 30 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot 1470133, exp. date 31 Mar 2016

Quantity recalled1859 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2350-2015
FDA event ID: 71614
Recalling firm: Remel, Lenexa, KS
Classification: Class II
Status: Terminated
Recall initiated: 30 Jun 2015
FDA classified: 7 Aug 2015
Reported: 19 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

30 Jun 2015	Recall initiated by company
7 Aug 2015	Classified by FDA	+38 days
19 Aug 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution, including Puerto Rico and the country of Canada.

Nationwide Puerto Rico

Stores named: Target

Questions about this recall

Is PathoDx Strep Grouping Kit recalled?

Yes. Remel recalled PathoDx Strep Grouping Kit on 30 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2350-2015.

Why was it recalled?

A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.

Which lots are affected?

lot 1470133, exp. date 31 Mar 2016

Where was it sold?

Nationwide Distribution, including Puerto Rico and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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