Recall record at a glance
| Official record | Z-0537-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Remel Inc. |
| Report date | Dec 25, 2013 |
| Recall initiation date | May 2, 2013 |
| Quantity | 768 kits |
| Location | Lenexa, KS, United States |
Official product description
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.
Why the product was recalled
The product may give weak or false negative test results.
Distribution information
Nationwide Distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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