Z-1992-2019Class II

C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen...

Name: Z-1992-2019 C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen...
Creator: Abbott Laboratories, Inc
Published: 2018-05-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-05-16 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories, Inc began a recall of C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in... on 2018-05-16. FDA classified it as Class II and gives the reason as "An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1992-2019
Classification: Class II
Status: Terminated
Initiated: 2018-05-16
Posted: 2019-07-19
Terminated: 2021-08-16
Recalling firm: Abbott Medical
Product: C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.
Product code: DBI Complement C4, Antigen, Antiserum, Control
Reason for recall: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated 5/16/2019 via FedEx priority overnight express on 5/16/2019 to the U.S. customers. For OUS, each country organization needs to establish their own method of notification, which normally consists of mailings or customer visits.
Quantity in commerce: 8,037 kits
Distribution: Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom, Uruguay, and Viet Nam.
Product codes and lots: All IFU's

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1992-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1987-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-19
Z-1988-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-19
Z-1989-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-19
Z-1990-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-19
Z-1991-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-19
Z-1992-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-19
Z-1993-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-19
Z-1994-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-19
Z-1995-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-19

Product code DBI

K983356Class IIC4Abbott Laboratories / cleared 1998-11-04

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)