Z-2038-2016Class II

SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number...

Name: Z-2038-2016 SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number...
Creator: Cell Marque Corporation
Published: 2016-05-10
License: https://open.fda.gov/license/

Cell Marque Corp. / initiated 2016-05-10 / Terminated

FDA source

Cell Marque Corporation began a recall of SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy... on 2016-05-10. FDA classified it as Class II and gives the reason as "Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2038-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-10
Posted: 2016-06-17
Terminated: 2016-09-23
Recalling firm: Cell Marque Corp.
Product: SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.
FDA root cause: Unknown/Undetermined by firm
Action: Product recall notifications were sent to customers on May 12, 2016. Letters advised that all unused or partially-used vials be destroyed. Customers should contact customer service for replacement and credit.
Quantity in commerce: 23 units
Distribution: Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.
Product codes and lots: Lot codes: 1335409A 1335409D 1335409B 1335409E 1335409C 1335409F.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2038-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2038-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-17

Product code NJT

K133845Class II8Mm Trocar KitIntuitive Surgical / cleared 2014-02-19

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)