Rocklin, CA, United States
Cell Marque Corporation recalls
2 recalls recorded since 2018, most recently on 15 July 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 15 July 2021
- Reason
- Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2311-2021
- Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Terminated Class II Medical devices
- Recall started
- 27 May 2021
- Terminated
- 5 April 2024
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2106-2021, Z-2105-2021
- Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
- Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.