CLASS II Device recall · Reported 25 Dec 2013 · FDA Enforcement Report

Streptex* kit recalled by Remel

Remel is recalling Streptex* kit, distributed nationwide in the US. The recall was initiated on 2 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 1192181, exp. January 2014

Quantity recalled768 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-0537-2014
FDA event ID: 65476
Recalling firm: Remel, Lenexa, KS
Classification: Class II
Status: Terminated
Recall initiated: 2 May 2013
FDA classified: 18 Dec 2013
Reported: 25 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

2 May 2013	Recall initiated by company
18 Dec 2013	Classified by FDA	+230 days
25 Dec 2013	Published in enforcement report	+7 days

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

Reason for recall

The product may give weak or false negative test results.

Product as listed by the FDA

Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Streptex* kit recalled?

Yes. Remel recalled Streptex* kit on 2 May 2013. The recall is Class II and its status is Terminated. Recall number Z-0537-2014.

Why was it recalled?

The product may give weak or false negative test results.

Which lots are affected?

Lot 1192181, exp. January 2014

Where was it sold?

Nationwide Distribution

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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