Device recall: VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No.…

Class III FDA enforcement event 74346. Recall start date: 9 May 2016. Status in the FDA record: Terminated. Termination date: 8 Jun 2018.

Reason for recall, in the words of FDA

Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

ORTHO-CLINICAL DIAGNOSTICS started this device recall on 9 May 2016. The firm address in the FDA record is in Bridgend. FDA put the recall in Class III. FDA event 74346 has 1 product record. The first FDA enforcement report date is 20 Jul 2016. The record gives the status Terminated, with the termination date 8 Jun 2018.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide Distribution

Recalling firm

ORTHO-CLINICAL DIAGNOSTICS, Bridgend, United Kingdom.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 74346: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2145-2016	VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were…	US: Lot 6471 - 282, Lot 6480 - 344	Class III	Terminated	20 Jul 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class III: 5%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 105

Other events of the firm

Other FDA enforcement events of ORTHO-CLINICAL DIAGNOSTICS
Initiated	Product (first record)	Type	Class	Records
27 Feb 2024	VITROS Performance Verifier I	Device	Class II	2
5 Jun 2023	VITROS Immunodiagnostic Products Troponin I ES Reagent Pack	Device	Class II	2
8 May 2023	VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- U	Device	Class II	1
20 Jul 2020	VITROS XT3400 Chemistry System, Product code 6844458	Device	Class II	2
17 Jul 2020	VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage:	Device	Class II	2
13 Jul 2020	VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL)	Device	Class II	3
20 May 2020	VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750	Device	Class II	5
11 May 2020	VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Prod	Device	Class II	4
1 Apr 2020	VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 -	Device	Class II	2
10 Mar 2020	VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468	Device	Class III	1

ORTHO-CLINICAL DIAGNOSTICS: all 105 events

Official channels

FDA enforcement report Z-2145-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 74346. https://recallregister.com/fda/iii/74346/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide Distribution
What quantity of product is in FDA event 74346?: The FDA record gives this quantity: US: Lot 6471 - 282, Lot 6480 - 344
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 5% of the 1,232 device events that started in 2016 are in Class III.