Z-2205-2017Class II

Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro...

Name: Z-2205-2017 Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro...
Creator: Cell Marque Corporation
Published: 2017-05-05
License: https://open.fda.gov/license/

Cell Marque Corp. / initiated 2017-05-05 / Terminated / root cause: labeling and UDI

FDA source

Cell Marque Corporation began a recall of Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent on 2017-05-05. 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 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2205-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-05
Posted: 2017-06-01
Terminated: 2017-09-07
Recalling firm: Cell Marque Corp.
Product: Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Product code: LKC Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus
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: 3
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: 7.0 ml lot 1432301A, expiry 2017-10; lot 1525206A , expiry 201 8-08.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2205-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2199-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2200-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2201-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2202-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2203-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2204-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2205-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2206-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2207-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2208-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2209-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01
Z-2210-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01

Product code LKC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)