FDA Medical Device Recalls (openFDA)
Cell Marque Corporation: H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Recall number
- Z-2202-2017
- Recalling firm
- Cell Marque Corporation
- Product
- H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Status
- Terminated
- Initiated
- 2017-05-05
- Posted
- 2017-06-01
- Terminated
- 2017-09-07
- 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.
- Root cause
- Labeling mix-ups
- Action
- Cell Marque sent notification letters by e-mail directly to domestic customers who were shipping affected products on May 9, 2017. Letters asked that unused product be destroyed and that amount destroyed and amount already used be recorded on the acknowledgment form and returned per instructions. UPDATE: Firm called DO on May 24, 2017 to inform us that the recall letters did not go out as expected on May 9, 2917 due to employee not performing assigned task. Director of Quality made sure letters went out on May 24th by e-mail and has already received some responses. She will also follow op with personal phone calls. Customers with questions were instructed to contact their Customer Care team at 800-665-7284 or 916-746-8900 or email sevrice@cellmarque.com. For questions regarding this recall call 916-746-8977.
- Quantity
- 5
- Distribution
- Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
- Lot, serial or model codes
- 1.0 ml lot 1611307C, expiry 201 9-03.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OWF
- Firm FEI
- 3000718726
- Firm city
- Rocklin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28