Z-2202-2017Class II
H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro...
Cell Marque Corp. / initiated 2017-05-05 / Terminated / root cause: labeling and UDI
Cell Marque Corporation began a recall of H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-2202-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Cell Marque Corp.
- Product
- H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Product code
- OWF Immunohistochemical Assay, Helicobacter Pylori
- Reason for recall
- 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 tag
- labeling and UDI
- FDA 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 [email protected]. For questions regarding this recall call 916-746-8977.
- Quantity in commerce
- 5
- Distribution
- Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
- Product codes and lots
- 1.0 ml lot 1611307C, expiry 201 9-03.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2199-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2200-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2201-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2202-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2203-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2204-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2205-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2206-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2207-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2208-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2209-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2210-2017 | Class II | Terminated | Voluntary: Firm initiated |
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