Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Summary
The FDA issued a Class II for Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: by Cell Marque Corporation. Reason: Product distributed for use as an In-vitro Diagnostics without FDA clearance.
Details
Source
Device Recall
External ID
Z-2105-2021
Action Date
2021-07-28
Status
Terminated
Category
device
Product Description
Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Lot/Code Info: Lot Numbers: 0000058081/ Exp: 31 Dec 2021, 0000072580/ Exp: 30 Sep 2021, 0000090505/ Exp: 30 Sep 2022, 0000121052/ Exp: 31 May 2023
Quantity Affected: 41 kits
Reason for Recall
Product distributed for use as an In-vitro Diagnostics without FDA clearance
Distribution
US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-27
Company
Rocklin, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cell Marque Corporation has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cell Marque Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cell Marque Corporation have FDA actions?
Cell Marque Corporation has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2105-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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