Device recall: ACCU-CHEK Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the…

Class II FDA enforcement event 69821. Recall start date: 20 Nov 2014. Status in the FDA record: Terminated. Termination date: 10 Jan 2018.

Reason for recall, in the words of FDA

Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Roche Diagnostics Operations, Inc. started this device recall on 20 Nov 2014. The firm address in the FDA record is in Indianapolis, IN. FDA put the recall in Class II. FDA event 69821 has 12 product records. The first FDA enforcement report date is 7 Jan 2015. The record gives the status Terminated, with the termination date 10 Jan 2018.

FDA enforcement report The 12 product records

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

Roche Diagnostics Operations, Inc., Indianapolis, IN.

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

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

Products

12 product records in the event.

FDA event 69821: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0883-2015	ACCU-CHEK Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0884-2015	ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0885-2015	ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0886-2015	ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0887-2015	ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0888-2015	ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0889-2015	ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0890-2015	ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0891-2015	ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0892-2015	ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0893-2015	ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015
Z-0894-2015	ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling…	Total of 13,041 boxes	Class II	Terminated	7 Jan 2015

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 II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2014: 1,176
Share of these events in Class II: 91%
Product records in this event: 12Median of the firm: 1
Events of the firm on the register: 69

Other events of the firm

Other FDA enforcement events of Roche Diagnostics Operations, Inc.
Initiated	Product (first record)	Type	Class	Records
20 Jan 2026	cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502	Device	Class II	1
21 Nov 2025	The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and el	Device	Class II	1
17 Oct 2024	cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for	Device	Class II	1
15 Aug 2024	Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determina	Device	Class II	1
3 Oct 2023	Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 31	Device	Class II	1
12 Dec 2022	cobas infinity central lab, Material Number 07154003001	Device	Class II	1
14 Jul 2022	cobas e801 Immunoassay Analyzer	Device	Class II	1
18 Oct 2021	Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of th	Device	Class II	1
24 Jun 2021	cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001	Device	Class II	1
26 Apr 2021	IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for th	Device	Class II	1

Roche Diagnostics Operations, Inc.: all 69 events

Official channels

FDA enforcement report Z-0883-2015The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 69821. https://recallregister.com/fda/ii/69821/. 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 69821?: The event has 12 product records. The first record gives this quantity: Total of 13,041 boxes
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2014 have the same class?: 91% of the 1,176 device events that started in 2014 are in Class II.