Z-3123-2017Class II

Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD)...

Name: Z-3123-2017 Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD)...
Creator: Leica Biosystems Richmond Inc.
Published: 2017-07-14
License: https://open.fda.gov/license/

Leica Biosystems Richmond, Inc. / initiated 2017-07-14 / Terminated

FDA source

Leica Biosystems Richmond Inc. began a recall of Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is... on 2017-07-14. FDA classified it as Class II and gives the reason as "A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3123-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-14
Posted: 2017-09-12
Terminated: 2024-08-02
Recalling firm: Leica Biosystems Richmond, Inc.
Product: Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
FDA root cause: Storage
Action: Advance Cancer Diagnostics sent an Urgent Medical Device Recall letter dated July 12, 2017, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to identify any affected products, discard them, and complete and return the Medical Device Acknowledgement Form by fax to 1-847-236-3000. For questions regarding this recall call 815-678-2000.
Quantity in commerce: 13
Distribution: Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
Product codes and lots: Product Code PA0804, Lot No. 45973, Exp. Date 05/21/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3123-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3120-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12
Z-3121-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12
Z-3122-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12
Z-3123-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12
Z-3124-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12
Z-3125-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12
Z-3126-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12

Product code NJT

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)