CLASS II Device recall · Reported 25 Dec 2013 · FDA Enforcement Report
Streptex* Latex D recalled by Remel
Remel is recalling Streptex* Latex D, 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
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-0538-2014
- 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* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Streptex* Latex D recalled?
Yes. Remel recalled Streptex* Latex D on 2 May 2013. The recall is Class II and its status is Terminated. Recall number Z-0538-2014.
Why was it recalled?
The product may give weak or false negative test results.
Which lots are affected?
Lot 1149576, 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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