FDA Device recall Z-2202-2017
H. pylori (polyclonal} 1.0 mL Catalog number 215A-76
- FDA Device
- Class II
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class II recall of H. pylori (polyclonal} 1.0 mL Catalog number 215A-76 by Cell Marque, citing cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as requi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2202-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-05 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cell Marque |
| Distribution | US |
Product
H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Reason
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
Identifiers
| code_info | 1.0 ml lot 1611307C, expiry 201 9-03. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2202-2017%22
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