CLASS II Device recall · Reported 7 Jun 2017 · FDA Enforcement Report
Varicella Zoster Virus recalled by Cell Marque
Cell Marque is recalling Varicella Zoster Virus, distributed nationwide in the US. The recall was initiated on 5 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2208-2017
- FDA event ID
- 77209
- Recalling firm
- Cell Marque, Rocklin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 May 2017
- FDA classified
- 1 Jun 2017
- Reported
- 7 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 5 May 2017 | Recall initiated by company | |
| 1 Jun 2017 | Classified by FDA | +27 days |
| 7 Jun 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Where it was distributed
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
Nationwide CaliforniaColoradoDelawareFloridaGeorgiaIllinoisKentuckyMassachusettsMarylandMississippiNorth CarolinaNew JerseyNew YorkOhioOklahomaOregonPennsylvaniaTexas
Questions about this recall
Is Varicella Zoster Virus recalled?
Yes. Cell Marque recalled Varicella Zoster Virus on 5 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2208-2017.
Why was it recalled?
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.
Which lots are affected?
7.0 ml lot 15261038, Expiry 2018-08
Where was it sold?
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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