Z-2105-2021Class II

Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN...

Name: Z-2105-2021 Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN...
Creator: Cell Marque Corporation
Published: 2021-05-27
License: https://open.fda.gov/license/

Cell Marque Corp. / initiated 2021-05-27 / Terminated / root cause: manufacturing process

FDA source

Cell Marque Corporation began a recall of Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798 on 2021-05-27. FDA classified it as Class II and gives the reason as "Product distributed for use as an In-vitro Diagnostics without FDA clearance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2105-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-27
Posted: 2021-07-21
Terminated: 2024-04-05
Recalling firm: Cell Marque Corp.
Product: Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Product code: MVU Reagents, Specific, Analyte
Reason for recall: Product distributed for use as an In-vitro Diagnostics without FDA clearance
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 27, 2021, Cell Marque Corporation issued a "Recall Notification" via e-mail to all affected consignee. On June 15, 2021 the firm issued a "Urgent Medical Device Recall Notification" to provide additional information. This communication was sent via e-mail. In addition to informing consignees about the recall, the firm asked customers to take the following actions: 1. Please immediately examine your inventory to determine if you have any remaining impacted product and forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. 2.Cell Marque is requesting that you destroy any unused or partially used containers of the products and that you provide us with confirmation that the product has been destroyed. If you have already used all the products, please confirm that the product has been used and is no longer available. Please complete the Attachment 1 confirmation of receipt form and return to local contact indicated below. 3. In addition, if you may have further distributed the product, please identify your customers and notify them of this issue immediately. Your notification to customers should include a copy of this notification. 4. Technical Services: Toll free at 800.665.7284 | Press 1. Additionally, email us at [email protected] 5. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 41 kits
Distribution: US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A
Product codes and lots: Lot Numbers: 0000058081/ Exp: 31 Dec 2021, 0000072580/ Exp: 30 Sep 2021, 0000090505/ Exp: 30 Sep 2022, 0000121052/ Exp: 31 May 2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2105-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2105-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-21
Z-2106-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-21

Product code MVU

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)