Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 25, 2013
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
The product may give weak or false negative test results.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Remel Inc recalled Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 t… - a moderate-severity action.
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 t… was recalled by Remel Inc in December 25, 2013. Reason: The product may give weak or false negative test results.. Check the official notice for the remedy. Verify recall #Z-0538-2014 with the FDA Devices before acting.
The recall
Remel Inc issued this moderate-severity FDA Devices recall-The product may give weak or false negative test results..
- Moderate
- severity level
- Class II
- classification
- December 25, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0538-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0538-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on May 2, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Remel Inc is listed as the recalling firm, operating out of Lenexa, KS. Federal records list the affected scope as 109 kits.
The documented reason for this recall is: The product may give weak or false negative test results. Distribution data in the federal record shows the product reached: Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
109 kits
Related Recalls
6
3 from same agency
Product description
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
Reason for recall
The product may give weak or false negative test results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0538-2014 |
| Date reported | December 25, 2013 |
| Date initiated | May 2, 2013 |
| Recalling firm | Remel Inc |
| Firm location | Lenexa, KS |
| Affected scope | 109 kits |
| Distribution | Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0538-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Remel Inc. Units affected: 109 kits.
Why was this product recalled? ▼
The product may give weak or false negative test results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0538-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0538-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 25, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.